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

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ClinicalTrials.gov 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
Sponsor:
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
Enrollment 112

Recruitment Details  
Pre-assignment Details  
Arm/Group Title StomaphyX Sham Procedure
Hide Arm/Group Description

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

No intervention

Sham procedure: False procedure

Period Title: Overall Study
Started 73 39
Completed 69 39
Not Completed 4 0
Reason Not Completed
Discontinuation prior to procedure             4             0
Arm/Group Title StomaphyX Sham Procedure Total
Hide Arm/Group Description

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

No intervention

Sham procedure: False procedure

Total of all reporting groups
Overall Number of Baseline Participants 69 39 108
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 39 participants 108 participants
49  (8.62) 49  (7.35) 49  (8.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 39 participants 108 participants
Female
67
  97.1%
35
  89.7%
102
  94.4%
Male
2
   2.9%
4
  10.3%
6
   5.6%
1.Primary Outcome
Title Weight Loss
Hide Description A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI < 35.
Time Frame 12 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
When futility analysis was performed, only 46 out of 108 patients had reached the 12 month primary endpoint. Analysis was performed on the 29 StomaphyX-treated patients to determine whether study objectives were met. Sham (control) patients were not analyzed.
Arm/Group Title StomaphyX Sham
Hide Arm/Group Description:

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

No intervention
Overall Number of Participants Analyzed 29 0
Measure Type: Number
Unit of Measure: participants
9
2.Secondary Outcome
Title Quality of Life
Hide Description Quality of life as assessed by the Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite); a ≥ 10 total score improvement from baseline (screening) will represent a clinically significant improvement.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary endpoint was not analyzed.
Arm/Group Title StomaphyX Sham Procedure
Hide Arm/Group Description:

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

No intervention

Sham procedure: False procedure

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title StomaphyX Sham
Hide Arm/Group Description

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

No intervention
All-Cause Mortality
StomaphyX Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
StomaphyX Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/69 (4.35%)      0/39 (0.00%)    
Infections and infestations     
Tachycardia, Infection *  1/69 (1.45%)  1 0/39 (0.00%)  0
Injury, poisoning and procedural complications     
Perforation * [1]  1/69 (1.45%)  1 0/39 (0.00%)  0
Vomiting *  1/69 (1.45%)  1 0/39 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Small perforation in posterior gastrojejunostomy anastomosis.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
StomaphyX Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/69 (26.09%)      7/39 (17.95%)    
Injury, poisoning and procedural complications     
Nausea   2/69 (2.90%)  2 1/39 (2.56%)  1
Sore Neck *  1/69 (1.45%)  1 0/39 (0.00%)  0
Temporary epigastric or abdominal pain  [1]  11/69 (15.94%)  11 1/39 (2.56%)  1
Pharyngolaryngeal pain (e.g. throat pain)   1/69 (1.45%)  1 2/39 (5.13%)  2
Burps a lot after eating *  1/69 (1.45%)  1 0/39 (0.00%)  0
Diarrhea *  1/69 (1.45%)  1 1/39 (2.56%)  1
Constipation *  0/69 (0.00%)  0 1/39 (2.56%)  1
Headache *  0/69 (0.00%)  0 1/39 (2.56%)  1
Temporary dysphagia (i.e. difficulty swallowing) * [2]  1/69 (1.45%)  1 0/39 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
can be treated with standard pain medication
[2]
due to swelling
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EndoGastric Solutions
ClinicalTrials.gov 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