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The EVICEL® Gastrointestinal Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01589822
First received: April 30, 2012
Last updated: February 24, 2015
Last verified: February 2015
Results First Received: July 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Gastrointestinal Diseases
Intervention: Biological: EVICEL Fibrin Sealant

  Participant Flow
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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
EVICEL Fibrin Sealant: Randomized

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.

EVICEL Fibrin Sealant: Intraoperative

Standard of Care Standard surgical technique for GI anastomosis.
Experimental: EVICEL Fibrin Sealant: Non-Randomized

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

EVICEL Fibrin Sealant: Intraoperative


Participant Flow:   Overall Study
    EVICEL Fibrin Sealant: Randomized     Standard of Care     Experimental: EVICEL Fibrin Sealant: Non-Randomized  
STARTED     84     89     41  
COMPLETED     80     86     40  
NOT COMPLETED     4     3     1  
Withdrawal by Subject                 1                 2                 0  
Death                 1                 0                 0  
Missed 90 day visit                 2                 1                 1  



  Baseline Characteristics
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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.
Subjects enrolled who consented and were randomized into the study or assigned to the non-randomized portion and had the investigational product applied were included in the analysis sets. The Safety Set consists of 125 subjects treated with EVICEL (41 Non- Randomized) and 89 subjects treated with Standard of Care.

Reporting Groups
  Description
EVICEL Fibrin Sealant: Randomized

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.

EVICEL Fibrin Sealant: Intraoperative

Standard of Care Standard surgical technique for GI anastomosis.
Experimental: EVICEL Fibrin Sealant: Non-Randomized

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

EVICEL Fibrin Sealant: Intraoperative

Total Total of all reporting groups

Baseline Measures
    EVICEL Fibrin Sealant: Randomized     Standard of Care     Experimental: EVICEL Fibrin Sealant: Non-Randomized     Total  
Number of Participants  
[units: participants]
  84     89     41     214  
Age  
[units: years]
Mean (Standard Deviation)
  61.1  (11.1)     62.5  (10.8)     62.0  (12.2)     61.8  (11.1)  
Gender  
[units: participants]
       
Female     41     33     21     95  
Male     43     56     20     119  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     21     21     8     50  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     0     1     1  
White     61     65     31     157  
More than one race     0     0     0     0  
Unknown or Not Reported     2     3     1     6  
Region of Enrollment  
[units: participants]
       
United States     15     17     13     45  
Canada     2     2     4     8  
Belgium     17     17     3     37  
Australia     10     9     6     25  
New Zealand     10     10     1     21  
United Kingdom     10     14     7     31  
Korea, Republic of     20     20     7     47  



  Outcome Measures
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1.  Primary:   Absence of Gastrointestinal (GI) Leak   [ Time Frame: 40 days ]

2.  Secondary:   Incidence of Adverse Events   [ Time Frame: up to Day 90 ]

3.  Secondary:   Incidence of GI Leak   [ Time Frame: 90 days ]

4.  Secondary:   Incidence of Stricture   [ Time Frame: up to Day 90 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Development
Organization: Ethicon
phone: 1 908 218-2492
e-mail: JBatill2@its.jnj.com



Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01589822     History of Changes
Other Study ID Numbers: 400-11-002
Study First Received: April 30, 2012
Results First Received: July 16, 2014
Last Updated: February 24, 2015
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
New Zealand: Medsafe