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.)
Sponsor:
Information provided by (Responsible Party):
EndoGastric Solutions
ClinicalTrials.gov Identifier:
NCT00939055
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
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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
  Description
StomaphyX

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


Participant Flow:   Overall Study
    StomaphyX     Sham Procedure  
STARTED     73     39  
COMPLETED     69     39  
NOT COMPLETED     4     0  
Discontinuation prior to procedure                 4                 0  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

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
e-mail: gsahyun@endogastricsolutions.com


No publications provided by EndoGastric Solutions

Publications automatically indexed to this study:

Responsible Party: EndoGastric Solutions
ClinicalTrials.gov 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