N/A
N=25
Use of Radiofrequency Ablation for RGB Salvage
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01910688 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Jun 2016
Primary outcome: Primary: Excess Body Weight Loss After RFA Treatment — 28.36 percentage of EBWL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RFA treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Excess Body Weight Loss After RFA Treatment |
28.36 | — |
| SECONDARY Technical Feasibility: Percentage of Participants Who Completed RFA Treatment |
84; 95.45; 94.44 | — |
| SECONDARY Patient Tolerability |
12 | — |
| SECONDARY Adverse Events |
6; 2; 3 | — |
Summary
The present study will assess the feasibility of using endoscopic radiofrequency ablation (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance after a failed Roux-en-Y gastric bypass.
Eligibility Criteria
Inclusion Criteria
- History of RGB surgery at least 1 year prior to enrollment
- Achievement of > 40% EBWL after RGB
- Weight regain of > 25% of the lost weight at the time of enrollment. For example, if excess body weight was 50 kg prior to RGB, patient must have lost at least 20 kg after RGB, then regained at least 5 kg to be eligible for the present study
- Age 18-70 inclusive
- Subject is able to tolerate endoscopy and sedation
- Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form (ICF)
Exclusion Criteria
- History of any bariatric surgery other than RGB, including lap band
- History or presence of a gastrogastric fistula or gastric pouch / jejunal ulceration
- Gastrojejunostomy > 4 cm in diameter (size estimated at time of endoscopy)
- Perceived inability of the patient by the Investigator to comply with a post-treatment diet or medication regimen
- History of alcohol, tobacco and/or controlled substance dependency that would impair the patient from complying with protocol requirements
- Pregnancy
- Subject is unable to provide informed consent for this study
Data sourced from ClinicalTrials.gov (NCT01910688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.