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

Sponsor:	EndoGastric Solutions
Information provided by:	EndoGastric Solutions
ClinicalTrials.gov Identifier:	NCT00939055

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	Procedure: StomaphyX Procedure: Sham procedure	Phase II Phase III

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:

MedlinePlus related topics: Obesity Weight Control

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-RNYGH 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.

Estimated Enrollment:	150
Study Start Date:	July 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Revisional procedure	Procedure: 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	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:	Pojai Phattanagosai, Clinical Research Associate, EndoGastric Solutions
ClinicalTrials.gov Identifier:	NCT00939055 History of Changes
Other Study ID Numbers:	D00764
Study First Received:	July 10, 2009
Last Updated:	July 6, 2011
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 February 08, 2012