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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, 2013
Last verified: May 2013
History of Changes
  Purpose

The Roux-en-Y gastric bypass (RNYGB) is a weight loss surgery that involves the creation of a small gastric pouch and rearrangement of the small intestine. Although RNYGB has been demonstrated as an effective bariatric procedure, a significant number of patients experience weight regain that is often associated with distended gastric anatomy. Open and laparoscopic approaches for revision are associated with higher complication rates than de novo procedures. This study will evaluate the safety and effectiveness of a revisional incisionless natural orifice surgery of the gastric pouch and stoma in producing weight loss in post-RNYGB patients who have experienced weight regain.


Condition Intervention Phase
Obesity
 Device: StomaphyX
Procedure: Sham procedure
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EndoGastric Solutions:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI < 35.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 respresent a clinically significant improvement.


Enrollment: 112
Study Start Date: July 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: StomaphyX
Post-Roux-en-Y revisional surgery using the StomaphyX device.
 Device: StomaphyX
Revisional incisionless natural orofice surgery of gastric pouch and stoma. GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications
Other Name: Revisional NOS
Sham Comparator: Sham Procedure
No intervention
 Procedure: Sham procedure
False procedure
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age and less than 65 years of age
  • BMI of at least 35 and no more than 40
  • At least 2 years post-RNYGB surgery
  • Initially achieved at least 60% EBL and a BMI 35 or less
  • Regained at least 20% of pre-RNYGB excess weight at screening
  • Stable weight or continued failure to lose weight for at least 3 months
  • Enlarged gastric pouch (≥ 30 ml)
  • Anatomy of upper GI judged suitable for revision using StomaphyX
  • Completed successful nutritional screening
  • Normal levels of vitamin D, iron/ferritin, calcium, and magnesium
  • Absence of protein malnutrition confirmed by serum albumin > 3 g/dL
  • Willing to cooperate with follow-up dietary recommendations and assessment tests
  • Signed Informed Consent

Exclusion Criteria:

  • Previous revisional bariatric surgery after RNYGB
  • Esophageal stricture or any anatomic condition that precludes passage of the StomaphyX device to the gastric pouch
  • Diabetes type I
  • Causal factors for weight regain other than gastric pouch enlargement
  • Serious complications experienced during and/or after RNYGB such as leaks, fistula, incisional hernia, ulcers, pulmonary embolism or deep venous thrombosis
  • Pregnancy or plans of pregnancy in the next 12 months
  • Immunosuppression
  • ASA > 3
  • Life expectancy less than one year
  • An eating disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed, Washington DC, American Psychiatric Association, 2000
  • Active substance abuse
  • Plans of smoking cessation in the next 12 months
  • Treatment with weight-loss prescription drug therapy within three months preceding the screening
  • Intention to use prescription drug therapy or the use of over-the-counter weight-loss preparations during the current study
  • Current participant in another weight-loss study or other clinical trial
  • Inflammatory bowel disease
  • Presence of ulceration at the gastrojejunostomy anastomosis
  • Portal hypertension
  • Coagulation disorders or chronic use of anticoagulants
  • Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939055

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
EndoGastric Solutions
Investigators
Principal Investigator: Anita P. Courcoulas, MD MPH FACS University of Pittsburgh
  More Information

No publications provided

Responsible Party: EndoGastric Solutions
ClinicalTrials.gov Identifier: NCT00939055     History of Changes
Other Study ID Numbers: D00764
Study First Received: July 10, 2009
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013