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

Not Applicable

Terminated

Conditions: Obesity

Interventions: Device: StomaphyX
Procedure: Sham procedure

Registration Number: NCT00939055

Lead Sponsor: EndoGastric Solutions

Brief Summary: 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.

Detailed Description: The Roux-en-Y gastric bypass (RNYGB) is the most commonly performed bariatric procedure to treat morbid obesity 1. Numerous studies have documented the effectiveness of RNYGB in promoting excess weight loss (EWL) typically in the 65-80% range after 1.5 to 2 years 1. Despite the favorable short-term outcomes of this bariatric surgical procedure, approximately 10-40% of patients do not achieve successful long-term weight loss 2. The weight regain occurs typically within 2 to 7 years after RNYGB surgery and is associated primarily with dilation of the gastric pouch or stoma 3, 4. Several open and laparoscopic bariatric revision procedures have been used in an attempt to correct these dilations, but they all have been associated with serious complications such as perforations, obstruction, staple line disruption, blind loop syndrome, stoma ulcer, and incisional hernias 2, 5, 6. Because of this high rate of morbidity associated with revisional gastric bypass surgery, less invasive endoscopic procedures may become a preferred approach for weight regain after RNYGB 7, 8.

The StomaphyX delivery system with SerosaFuse fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants. The unit is provided sterile and is a single use device. The polypropylene fasteners are proprietary and function only with the StomaphyX device. The device uses vacuum to invaginate tissue through a port into a chamber and fasten it using the H shaped polypropylene fasteners. The fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue. Durability of the SerosaFuse fasteners has been demonstrated during several clinical studies utilizing the EsophyX device 9-12.

Reason for Conducting the Present Study: The goal of this study was to investigate the safety and effectiveness of the StomaphyX device for revisional natural orifice surgery of the gastric pouch and gastrojejunostomy anastomosis (stoma) in RNYGB patients to reduce regained weight.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 112

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
StomaphyX	StomaphyX	Post-Roux-en-Y revisional surgery using the StomaphyX device.
Sham Procedure	Sham procedure	No intervention

Primary Outcome Measures

Name	Time	Method
Weight Loss	12 month	A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI \< 35.

Secondary Outcome Measures

Name	Time	Method
Assessment of Changes to Quality of Life (QOL) Using a Validated QOL Questionnaire	12 months	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.

Trial Locations

Locations (2): The Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States