Endoscopic Suturing System for Tissue Apposition

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. Identifier: NCT00495222
Recruitment Status : Completed
First Posted : July 3, 2007
Results First Posted : August 11, 2009
Last Update Posted : September 10, 2009
Information provided by:
Ethicon Endo-Surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Procedure: Tissue plication
Device: Endoscopic Suturing System
Device: Tissue Plication

  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
Tissue Plication No text entered.

Participant Flow:   Overall Study
    Tissue Plication

  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
Tissue Plication No text entered.

Baseline Measures
   Tissue Plication 
Overall Participants Analyzed 
[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

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: Susan Knippenberg
Organization: Ethicon Endo-Surgery
phone: 513 337-3452

Responsible Party: Susan Knippenberg, Ethicon Endo-Surgery Identifier: NCT00495222     History of Changes
Other Study ID Numbers: CI-06-0005
First Submitted: June 29, 2007
First Posted: July 3, 2007
Results First Submitted: April 21, 2009
Results First Posted: August 11, 2009
Last Update Posted: September 10, 2009