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Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates

This study has been completed.
Sponsor:
Information provided by:
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00721227
First received: July 9, 2008
Last updated: September 1, 2010
Last verified: September 2010
Results First Received: July 21, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Obesity
Intervention: Procedure: Reduction Gastroplasty

  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
Enrollment period started April 17, 2008. Enrollment continued until December 31, 2008. The followup period continued until January 29, 2010. Enrollment was conducted in the bariatric and research offices of The Cleveland Clinic Foundation, Cleveland, Ohio.

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
Anterior Curve Reduction Gastroplasty by Gastric Plication on Anterior Curve
Greater Curve Reduction Gastroplasty by Gastric Plication on Greater Curve

Participant Flow:   Overall Study
    Anterior Curve     Greater Curve  
STARTED     9     6  
COMPLETED     5 [1]   6  
NOT COMPLETED     4     0  
Lost to Follow-up                 3                 0  
Noncompliance with scheduled visits.                 1                 0  
[1] 3 subjects lost to follow up; 1 subject did not complete due to noncompliance of scheduled visits.



  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
Anterior Curve Reduction Gastroplasty by Gastric Plication on Anterior Curve
Greater Curve Reduction Gastroplasty by Gastric Plication on Greater Curve
Total Total of all reporting groups

Baseline Measures
    Anterior Curve     Greater Curve     Total  
Number of Participants  
[units: participants]
  9     6     15  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     6     15  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45.0  ± 10.37     36.8  ± 8.42     41.7  ± 10.19  
Gender  
[units: participants]
     
Female     6     6     12  
Male     3     0     3  
Region of Enrollment  
[units: participants]
     
United States     9     6     15  



  Outcome Measures
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1.  Primary:   Successful Gastric Plication Using Reduction Gastroplasty   [ Time Frame: Immediately post-operative ]

2.  Secondary:   Durability of Gastric Plications Following Reduction Gastroplasty   [ Time Frame: 12 month ]

3.  Secondary:   Weight Loss Following Reduction Gastroplasty   [ Time Frame: 12 months ]


  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: Amy Mahanes, Senior Clinical Research Associate
Organization: Ethicon Endo Surgery, Inc.
phone: 513-337-8366
e-mail: amahanes@its.jnj.com


No publications provided


Responsible Party: Amy Mahanes, Senior Clinical Research Associate, Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00721227     History of Changes
Other Study ID Numbers: CI-07-0005
Study First Received: July 9, 2008
Results First Received: July 21, 2010
Last Updated: September 1, 2010
Health Authority: United States: Institutional Review Board