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The SENTRY Clinical Study (SENTRY)

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: NCT01975090
Recruitment Status : Active, not recruiting
First Posted : November 4, 2013
Results First Posted : October 12, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Novate Medical

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Pulmonary Embolism
Deep Vein Thrombosis
Intervention: Device: SENTRY IVC Filter

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
SENTRY IVC Filter Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation.

Participant Flow:   Overall Study
    SENTRY IVC Filter
STARTED   129 
6-month Follow-up   117 
COMPLETED   117 
NOT COMPLETED   12 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
SENTRY IVC Filter Group Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation

Baseline Measures
   SENTRY IVC Filter Group 
Overall Participants Analyzed 
[Units: Participants]
 		 129 
Age 
[Units: Participants]
Count of Participants 		 
<=18 years   0 
Between 18 and 65 years   70 
>=65 years   59 
Age 
[Units: Years]
Mean (Standard Deviation) 		 62.6  (13.52) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      56  43.4% 
Male      73  56.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants 		 
Belgium   4 
United States   115 
Chile   10 


  Outcome Measures

1.  Primary:   Number of Subjects That Reported Clinical Success   [ Time Frame: 6 Months ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With IVC Filter Related Complications   [ Time Frame: 6months ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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:  
Name/Title: Gordon Crowley
Organization: Novate Medical
phone: +353 91 750 030
e-mail: gordon.crowley@novate.ie


Publications:


Responsible Party: Novate Medical
ClinicalTrials.gov Identifier: NCT01975090     History of Changes
Other Study ID Numbers: CI 036
First Submitted: October 28, 2013
First Posted: November 4, 2013
Results First Submitted: September 14, 2017
Results First Posted: October 12, 2017
Last Update Posted: February 5, 2018