Endoscopic Suturing System for Tissue Apposition

This study has been completed.
Information provided by:
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
First received: June 29, 2007
Last updated: September 8, 2009
Last verified: September 2009
Results First Received: April 21, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Obesity
Interventions: Procedure: Tissue plication
Device: Endoscopic Suturing System
Device: Tissue Plication

  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
Tissue Plication No text entered.

Participant Flow:   Overall Study
    Tissue Plication  
STARTED     9  

  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.
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Reporting Groups
Tissue Plication No text entered.

Baseline Measures
    Tissue Plication  
Number of Participants  
[units: participants]
[units: participants]
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     0  
[units: years]
Mean (Standard Deviation)
  35.5  (5.5)  
[units: participants]
Female     7  
Male     2  
Region of Enrollment  
[units: participants]
United States     9  

  Outcome Measures

1.  Primary:   Knotting Elements Placed   [ Time Frame: intra-operative ]

  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 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: Susan Knippenberg
Organization: Ethicon Endo-Surgery
phone: 513 337-3452
e-mail: sknippen@its.jnj.com

Responsible Party: Susan Knippenberg, Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00495222     History of Changes
Other Study ID Numbers: CI-06-0005
Study First Received: June 29, 2007
Results First Received: April 21, 2009
Last Updated: September 8, 2009
Health Authority: United States: Institutional Review Board