StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight

This study has been terminated.
(Based on futility analysis, study would not meet primary endpoint.)
Information provided by (Responsible Party):
EndoGastric Solutions Identifier:
First received: July 10, 2009
Last updated: May 28, 2014
Last verified: May 2014
Results First Received: March 24, 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: Obesity
Interventions: Device: StomaphyX
Procedure: Sham procedure

  Participant Flow

  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.
A total of 112 patients entered the study. 73 patients were randomized to the treatment study arm while 39 patients were randomized to the control study arm. 4 patients discontinued participation prior to receiving the study procedure. Therefore, 108 patients were eligible for follow-up.

Reporting Groups

Post-Roux-en-Y revisional surgery using the StomaphyX device.

StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.

GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications

Sham Procedure

No intervention

Sham procedure: False procedure

Total Total of all reporting groups

Baseline Measures
    StomaphyX     Sham Procedure     Total  
Number of Participants  
[units: participants]
  69     39     108  
[units: years]
Mean (Standard Deviation)
  49  (8.62)     49  (7.35)     49  (8.15)  
[units: participants]
Female     67     35     102  
Male     2     4     6  

  Outcome Measures
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1.  Primary:   Weight Loss   [ Time Frame: 12 month ]

2.  Secondary:   Quality of Life   [ 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: Senior Director Clinical Affairs
Organization: EndoGastric Solutions
phone: 650-823-9093

No publications provided by EndoGastric Solutions

Publications automatically indexed to this study:

Responsible Party: EndoGastric Solutions Identifier: NCT00939055     History of Changes
Other Study ID Numbers: D00764
Study First Received: July 10, 2009
Results First Received: March 24, 2014
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration