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

  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.
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 
Overall Participants Analyzed 
[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

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