Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy

This study has been completed.
Sponsor:
Information provided by:
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00553436
First received: November 2, 2007
Last updated: April 20, 2010
Last verified: April 2010
Results First Received: October 20, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Polyps
Intervention: Device: Tissue Apposition System (TAS) Device

  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
Single Center, hospital based surgical suite. Enrollment from 20 August 2007 to 09 April 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Non-randomized. Patients were considered for enrollment based on inclusion / exclusion criteria and were offered the opportunity for enrollment. Those that signed informed consent were enrolled.

Reporting Groups
  Description
Enrolled Subjects Treated With Tissue Apposition System (TAS) All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure

Participant Flow:   Overall Study
    Enrolled Subjects Treated With Tissue Apposition System (TAS)  
STARTED     7 [1]
COMPLETED     6 [2]
NOT COMPLETED     1  
Conversion to another procedure                 1  
[1] 20 August 2007
[2] 09 April 2009



  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.
No text entered.

Reporting Groups
  Description
Enrolled Subjects Treated With Tissue Apposition System (TAS) All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure

Baseline Measures
    Enrolled Subjects Treated With Tissue Apposition System (TAS)  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 8.36  
Gender  
[units: participants]
 
Female     3  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures
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1.  Primary:   Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS)   [ Time Frame: At The Time of Surgery ]

2.  Secondary:   Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition.   [ Time Frame: 3 month follow-up ]

3.  Secondary:   Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition   [ Time Frame: 3 month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Amy Mahanes, Clinical Research Associate II
Organization: Ethicon Endo-Surgery, Inc
phone: 513-337-8366
e-mail: amahanes@its.jnj.com


No publications provided by Ethicon Endo-Surgery

Publications automatically indexed to this study:

Responsible Party: Amy Mahanes, Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00553436     History of Changes
Other Study ID Numbers: CI-07-0004, UH IRB #07-07-08
Study First Received: November 2, 2007
Results First Received: October 20, 2009
Last Updated: April 20, 2010
Health Authority: United States: Institutional Review Board