We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The SENTRY Clinical Study (SENTRY)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01975090
First Posted: November 4, 2013
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Novate Medical
Results First Submitted: September 14, 2017  
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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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 [1] 
6-month Follow-up   117 
COMPLETED   117 
NOT COMPLETED   12 
[1] 1st Subject Enrolled



  Baseline Characteristics
  Hide 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.
No text entered.

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 [1] 
[Units: Participants]
Count of Participants
 
<=18 years   0 
Between 18 and 65 years   70 
>=65 years   59 
[1] > 18 years of age
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]
 
Belgium   4 
United States   115 
Chile   10 


  Outcome Measures

1.  Primary:   Clinical Success Rate of the Sentry IVC Filter   [ Time Frame: 6 Months ]

2.  Secondary:   (1) Technical Success (2) Filter Status (3) Symptomatic PE (4) Freedom From IVC Filter Related Complications   [ Time Frame: 1, 2, 6,12 and 24 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Other Pre-specified:   (1) New Symptomatic DVT(5) Procedure Related Serious Adverse Events (SAE) (2) New or Symptomatic Venous Thromboembolism   [ Time Frame: 1, 2, 6, 12 and 24 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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: October 12, 2017