Study Stopped
Based on futility analysis, study would not meet primary endpoint.
StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight
A Randomized Controlled Trial of StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight
1 other identifier
interventional
112
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jul 2009
Typical duration for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 10, 2009
CompletedFirst Posted
Study publicly available on registry
July 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
June 5, 2014
CompletedNovember 23, 2020
October 1, 2020
2.9 years
July 10, 2009
March 24, 2014
October 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Weight Loss
A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI \< 35.
12 month
Secondary Outcomes (1)
Assessment of Changes to Quality of Life (QOL) Using a Validated QOL Questionnaire
12 months
Study Arms (2)
StomaphyX
EXPERIMENTALPost-Roux-en-Y revisional surgery using the StomaphyX device.
Sham Procedure
SHAM COMPARATORNo intervention
Interventions
Transoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Eid GM, McCloskey CA, Eagleton JK, Lee LB, Courcoulas AP. StomaphyX vs a sham procedure for revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients : a randomized clinical trial. JAMA Surg. 2014 Apr;149(4):372-9. doi: 10.1001/jamasurg.2013.4051.
PMID: 24554030DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Affairs
- Organization
- EndoGastric Solutions
Study Officials
- PRINCIPAL INVESTIGATOR
Anita P. Courcoulas, MD MPH FACS
University of Pittsburgh Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2009
First Posted
July 14, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
November 23, 2020
Results First Posted
June 5, 2014
Record last verified: 2020-10