Trial Outcomes & Findings for StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight (NCT NCT00939055)

NCT ID: NCT00939055

Last Updated: 2020-11-23

Results Overview

A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI \< 35.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 112 participants
• Primary outcome timeframe: 12 month
• Results posted on: 2020-11-23

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	73	39
Overall Study COMPLETED	69	39
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Measure	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
Overall Study Discontinuation prior to procedure	4	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	StomaphyX n=69 Participants 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 n=39 Participants No intervention Sham procedure: False procedure	Total n=108 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 8.62 • n=5 Participants	49 years STANDARD_DEVIATION 7.35 • n=7 Participants	49 years STANDARD_DEVIATION 8.15 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	35 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 month

Population: 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.

A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI < 35.

Outcome measures

Measure	StomaphyX n=29 Participants 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 No intervention
Weight Loss	9 participants	—

SECONDARY outcome

Timeframe: 12 months

Population: Secondary endpoint was not analyzed.

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.

Outcome measures

Outcome data not reported

Adverse Events

StomaphyX

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	StomaphyX n=69 participants at risk 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 n=39 participants at risk No intervention
Injury, poisoning and procedural complications Perforation	1.4% 1/69 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	0.00% 0/39 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.
Infections and infestations Tachycardia, Infection	1.4% 1/69 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	0.00% 0/39 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.
Injury, poisoning and procedural complications Vomiting	1.4% 1/69 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	0.00% 0/39 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.

Other adverse events

Measure	StomaphyX n=69 participants at risk 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 n=39 participants at risk No intervention
Injury, poisoning and procedural complications Nausea	2.9% 2/69 • Number of events 2 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	2.6% 1/39 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.
Injury, poisoning and procedural complications Sore Neck	1.4% 1/69 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	0.00% 0/39 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.
Injury, poisoning and procedural complications Temporary epigastric or abdominal pain	15.9% 11/69 • Number of events 11 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	2.6% 1/39 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.
Injury, poisoning and procedural complications Pharyngolaryngeal pain (e.g. throat pain)	1.4% 1/69 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	5.1% 2/39 • Number of events 2 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.
Injury, poisoning and procedural complications Burps a lot after eating	1.4% 1/69 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	0.00% 0/39 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.
Injury, poisoning and procedural complications Diarrhea	1.4% 1/69 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	2.6% 1/39 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.
Injury, poisoning and procedural complications Constipation	0.00% 0/69 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	2.6% 1/39 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.
Injury, poisoning and procedural complications Headache	0.00% 0/69 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	2.6% 1/39 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.
Injury, poisoning and procedural complications Temporary dysphagia (i.e. difficulty swallowing)	1.4% 1/69 • Number of events 1 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.	0.00% 0/39 • Adverse event data were collected through the 12-month post-op visit for treatment and sham patients. The blind was broken for all patients due to premature termination of the study. 112 subjects enrolled/randomized:73 StomaphyX, 39 Sham. 108 treated:69 StomaphyX, 39 Sham. 112 patients were considered at risk for all cause mortality; 108 (69 StomaphyX, 39 Sham) considered at risk for serious/other adverse events. The 4 patients not included were in StomaphyX arm: 2 withdrawn prior to treatment at investigator discretion. Surgery was aborted on the other 2; treatment not completed as device couldn't be inserted. These 4 followed per site standard of care, outside study.

Additional Information

Senior Director Clinical Affairs

EndoGastric Solutions

Phone: 650-823-9093

Email: gsahyun@endogastricsolutions.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place