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Trial record 22 of 56 for:    "Lung Disease" | "Dalteparin"

Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH) (SAFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358735
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : October 21, 2014
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Medical Compression Systems

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Deep Vein Thrombosis of Lower Limb
Pulmonary Embolism (PE)
Bleeding
Interventions Device: ActiveCare CECT device
Drug: Enoxaparin
Enrollment 411
Recruitment Details Multi-center study. Recruitment began June 2006 and ended September 2008
Pre-assignment Details

Per protocol:. The pre-randomization evaluation (within 3 days of surgery, may be completed on admission) includes the following:

  • Review of inclusion/exclusion criteria (including evaluation for clinical signs and symptoms of DVT or PE)
  • Demographic parameters
  • Medical history
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital). Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Period Title: Overall Study
Started 204 207
Completed Safety 198 194
Not Completed Safety 6 13
Completed 196 [1] 190 [1]
Not Completed 8 17
[1]
Efficacy
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator) Total
Hide Arm/Group Description The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital). Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital). Total of all reporting groups
Overall Number of Baseline Participants 198 194 392
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 198 participants 194 participants 392 participants
63
(20 to 84)
62
(32 to 88)
62.5
(20 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 194 participants 392 participants
Female
109
  55.1%
105
  54.1%
214
  54.6%
Male
89
  44.9%
89
  45.9%
178
  45.4%
body-mass index (Kg/m2)  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 198 participants 194 participants 392 participants
28
(17 to 43)
29
(16 to 49)
28.5
(16 to 49)
Diagnosis of osteoarthritis (n)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 198 participants 194 participants 392 participants
Diagnosis 186 184 370
No Diagnosis 12 10 22
Duration of surgery (minutes)  
Mean (Full Range)
Unit of measure:  Minutes
Number Analyzed 198 participants 194 participants 392 participants
91
(44 to 168)
96
(41 to 190)
93.5
(41 to 190)
length of hospital stay (days)  
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 198 participants 194 participants 392 participants
3.2
(2 to 8)
3.2
(2 to 10)
3.2
(2 to 10)
1.Primary Outcome
Title Events of Deep Vein Thrombosis (DVT)
Hide Description

10-12 days post-op: All of the patients underwent Routine bilateral compression Doppler.

Day of surgery and up to 3 months post-op: Suspected clinical signs and symptoms DVT events were confirmed by standard diagnostic objective methods

Time Frame 10-12 days post-op; and from day of surgery and up to 3 months if symptomatic
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Overall Number of Participants Analyzed 196 190
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Hips Analyzed
197 192
Measure Type: Number
Unit of Measure: Events
Total DVT 8 8
Distal DVT 5 6
Proximal DVT 3 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ActiveCare+SFT (Experimental), LMWH (Enoxaparin) (Active Comparator)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Clinical PE (Pulmonary Embolism) Events
Hide Description Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT
Time Frame Day of surgery and up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Overall Number of Participants Analyzed 196 190
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Hips Analyzed
197 192
Measure Type: Number
Unit of Measure: Events
2 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ActiveCare+SFT (Experimental), LMWH (Enoxaparin) (Active Comparator)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Major Bleeding Complication
Hide Description Major bleeding is defined as bleeding that requires rehospitalization or prolonged hospitalization, requires any intervention such as surgery or hematoma aspiration to prevent permanent impairment or damage, endangered critical organs, is life threatening or causes death. Data collected included bleeding index, a decrease in hemoglobin greater than/equal to 20 g/L, and number of units of blood transfused.
Time Frame Up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Overall Number of Participants Analyzed 198 194
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Hips Analyzed
199 196
Measure Type: Number
Unit of Measure: Events
0 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ActiveCare+SFT (Experimental), LMWH (Enoxaparin) (Active Comparator)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title OutPatient Patients’ Compliance
Hide Description

Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.

The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of home treatment (for the entire arm/group).

The compliance is expressed as percentages.

Time Frame 10-12 days post-op
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Overall Number of Participants Analyzed 180
Measure Type: Number
Unit of Measure: percentage of usage time
83
5.Secondary Outcome
Title Serious Adverse Events
Hide Description

Serious Adverse Events (SAE) is any event that prolongs hospitalization or requires re-hospitalization, that requires intervention to prevent permanent impairment or damage, that causes permanent disability, or that is life threatening.

SAE did not include Venous thrombolembolism (VTE) events (DVT and PE) and Major bleeding complications as these are outcome measures

Time Frame SAE data were collected Up to 3 months post-op
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Overall Number of Participants Analyzed 198 194
Measure Type: Number
Unit of Measure: events
3 10
6.Secondary Outcome
Title In-Patients’ Compliance
Hide Description

Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.

The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of treatment at hospital (for the entire arm/group).

The compliance is expressed as percentages.

Time Frame Surgery till discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Overall Number of Participants Analyzed 180
Measure Type: Number
Unit of Measure: percentage of usage time
91
7.Post-Hoc Outcome
Title Events of Clinical Sign and Symptoms of VTE (DVT and/or PE)
Hide Description Events of clinical Sign and symptoms of VTE (DVT and/or PE), confirmed by standard objective diagnostic methods
Time Frame Day of surgery and up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Overall Number of Participants Analyzed 199 196
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Hips Analyzed
197 192
Measure Type: Number
Unit of Measure: Events
10 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ActiveCare+SFT (Experimental), LMWH (Enoxaparin) (Active Comparator)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.953
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Post-Hoc Outcome
Title Total Number of Blood Transfusion Units
Hide Description Number of blood units used (Autologous units and allogeneic units) (blood units during surgery not included)
Time Frame Between the immediate postoperative measurement and discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Overall Number of Participants Analyzed 198 194
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Hips Analyzed
199 196
Measure Type: Number
Unit of Measure: Units
82 122
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ActiveCare+SFT (Experimental), LMWH (Enoxaparin) (Active Comparator)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
9.Post-Hoc Outcome
Title Allogeneic Blood Transfusion Units
Hide Description Allogeneic blood transfusion per patient in specific treatment Group
Time Frame Up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Overall Number of Participants Analyzed 198 194
Mean (Standard Deviation)
Unit of Measure: Avg. Unit per patient in arm
0.13  (0.48) 0.32  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ActiveCare+SFT (Experimental), LMWH (Enoxaparin) (Active Comparator)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
10.Post-Hoc Outcome
Title Autologous Blood Transfusion Units
Hide Description Autologous blood transfusion per patient in specific treatment Group
Time Frame Up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Overall Number of Participants Analyzed 198 194
Mean (Standard Deviation)
Unit of Measure: Avg. Unit per patient in arm
0.28  (0.53) 0.3  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ActiveCare+SFT (Experimental), LMWH (Enoxaparin) (Active Comparator)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.507
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
11.Post-Hoc Outcome
Title Bleeding Index ≥ 2
Hide Description Bleeding index was defined as the number of units of whole blood or packed red blood cells transfused plus the difference between the first hemoglobin value after surgery and the value prior to discharge
Time Frame Surgery till discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Overall Number of Participants Analyzed 198 194
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.3  (1.04) 1.5  (1.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ActiveCare+SFT (Experimental), LMWH (Enoxaparin) (Active Comparator)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
12.Post-Hoc Outcome
Title Changes in Hemoglobin Levels
Hide Description Changes in Hemoglobin levels
Time Frame After surgery untill discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Overall Number of Participants Analyzed 198 194
Mean (Standard Deviation)
Unit of Measure: mean change (g/l)
8  (1.26) 9  (1.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ActiveCare+SFT (Experimental), LMWH (Enoxaparin) (Active Comparator)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.798
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
13.Post-Hoc Outcome
Title Composite Outcome of Major Bleeding + VTE
Hide Description Major bleeding + DVT events + PE Events
Time Frame Day of surgery and up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description:
The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
Overall Number of Participants Analyzed 196 190
Measure Type: Number
Unit of Measure: Events
10 21
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ActiveCare+SFT (Experimental), LMWH (Enoxaparin) (Active Comparator)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame SAE data were collected Up to 3 months post-op
Adverse Event Reporting Description SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures
 
Arm/Group Title ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Hide Arm/Group Description The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital). Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
All-Cause Mortality
ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/198 (1.52%)      10/194 (5.15%)    
Blood and lymphatic system disorders     
Thrombocytopenia (HIT?)   0/198 (0.00%)  1/194 (0.52%) 
Cardiac disorders     
Cardiac Disorders   0/198 (0.00%)  1/194 (0.52%) 
supraventricular cardiac arrhythmia   1/198 (0.51%)  2/194 (1.03%) 
Infections and infestations     
Fever due to aspiration   1/198 (0.51%)  0/194 (0.00%) 
Musculoskeletal and connective tissue disorders     
Dislocation   0/198 (0.00%)  5/194 (2.58%) 
Stress fracture   0/198 (0.00%)  1/194 (0.52%) 
Nervous system disorders     
Parkinson (new event)   1/198 (0.51%)  0/194 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
ActiveCare+SFT (Experimental) LMWH (Enoxaparin) (Active Comparator)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   89/198 (44.95%)      102/194 (52.58%)    
Blood and lymphatic system disorders     
Minor Bleeding  [1]  74/198 (37.37%)  74 78/194 (40.21%)  78
Edema   7/198 (3.54%)  7 22/194 (11.34%)  22
Skin and subcutaneous tissue disorders     
Skin irritation   8/198 (4.04%)  8 2/194 (1.03%)  2
Indicates events were collected by systematic assessment
[1]
Minor bleeding was any bleeding that was not major bleeding (e.g., increased wound drainage reported by the surgeon or a drop in the hemoglobin level not requiring transfusion or prolonged hospitalization).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clifford W Colwell, M.D Scripps Clinic
Organization: Medical Compression Systems
Phone: 972-4-6266630 ext 412
EMail: Jbarak@mcsmed.com
Layout table for additonal information
Responsible Party: Medical Compression Systems
ClinicalTrials.gov Identifier: NCT00358735     History of Changes
Other Study ID Numbers: MedicalCS06CC001
First Submitted: July 30, 2006
First Posted: August 1, 2006
Results First Submitted: September 14, 2014
Results First Posted: October 21, 2014
Last Update Posted: October 30, 2014