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

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: NCT00939055
Recruitment Status : Terminated (Based on futility analysis, study would not meet primary endpoint.)
First Posted : July 14, 2009
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Information provided by (Responsible Party):
EndoGastric Solutions

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Device: StomaphyX
Procedure: Sham procedure

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Participant Flow:   Overall Study
    StomaphyX   Sham Procedure
STARTED   73   39 
COMPLETED   69   39 
Discontinuation prior to procedure                4                0 

  Baseline Characteristics

  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

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
No text entered.

  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: Senior Director Clinical Affairs
Organization: EndoGastric Solutions
phone: 650-823-9093

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: EndoGastric Solutions Identifier: NCT00939055     History of Changes
Other Study ID Numbers: D00764
First Submitted: July 10, 2009
First Posted: July 14, 2009
Results First Submitted: March 24, 2014
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014