Use of Radiofrequency Ablation for RGB Salvage

• ClinicalTrials.gov Identifier: NCT01910688
• Recruitment Status: Completed
• First Posted: July 30, 2013
• Results First Posted: June 24, 2016
• Last Update Posted: June 24, 2016
• Sponsor: Medtronic - MITG
• Information provided by (Responsible Party): Medtronic - MITG

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Obesity	Device: RFA treatment	Not Applicable

Detailed Description:

Obesity is a leading cause of preventable death in the United States, with approximately 300,000 related deaths per year. The most commonly performed bariatric surgical interventions are Roux-en Y gastric bypass (RGB) and laparoscopic adjustable gastric band placement. Despite the overall initial success of RGB to induce significant EBWL in the majority of patients, significant weight regain occurs in about 25% of patients at 2+ years following surgery. Given the preliminary success of endoscopic, non-surgical salvage interventions for the failed (uncomplicated) RGB patient, 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. A reduction of size and compliance may, as others have reported, result in re-establish weight loss and achieve an acceptable EBWL with minimal patient morbidity.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Endoscopically Delivered Radiofrequency Ablation for the Treatment of Ptients Who Have Undergone Roux-en-Y Gastric Bypass and Have Failed to Achieve/ Maintain Satisfactory Excess Body Weight Loss
• Study Start Date: July 2013
• Actual Primary Completion Date: January 2016
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm

Intervention/treatment

Experimental: RFA treatment (Radiofrequency ablation); If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.

Device: RFA treatment; If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis.; Other Name: HALO60, HALO90, HALO90 Ultra

Outcome Measures

Primary Outcome Measures :

1. Excess Body Weight Loss After RFA Treatment [ Time Frame: 12 months ]
   EBWL 12 months after enrollment

Secondary Outcome Measures :

1. Technical Feasibility: Percentage of Participants Who Completed RFA Treatment [ Time Frame: Day 0, month 4, month 8 ]
   Technical feasibility of applying RFA to gastric pouch and gastrojejunostomy. This will be assessed by asking the physician for feedback on ease of use, ease of intubation and extubation,did the physician achieve tissue contact in targeted areas, was targeted area successfully ablated.
2. Patient Tolerability [ Time Frame: 12 months ]
   Patient tolerability of the procedure. Patient tolerability will be measured by assessing adverse events related to the device or procedure. The Investigator will assess each adverse event with respect to severity and relationship to the study device.
3. Adverse Events [ Time Frame: 12 months ]
   Adverse event profile: Relationship to study device : Definite, Probable, Possible

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. History of RGB surgery at least 1 year prior to enrollment
2. Achievement of > 40% EBWL after RGB
3. 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
4. Age 18-70 inclusive
5. Subject is able to tolerate endoscopy and sedation
6. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form (ICF)

Exclusion Criteria:

1. History of any bariatric surgery other than RGB, including lap band
2. History or presence of a gastrogastric fistula or gastric pouch / jejunal ulceration
3. Gastrojejunostomy > 4 cm in diameter (size estimated at time of endoscopy)
4. Perceived inability of the patient by the Investigator to comply with a post-treatment diet or medication regimen
5. History of alcohol, tobacco and/or controlled substance dependency that would impair the patient from complying with protocol requirements
6. Pregnancy
7. Subject is unable to provide informed consent for this study

Contacts and Locations

Locations

United States, New Hampshire

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

United States, New York

Columbia Univeristy

New York, New York, United States, 10032

Sponsors and Collaborators

Medtronic - MITG

Investigators

• Principal Investigator: Julian Abrams, MD; Columbia University
• Principal Investigator: Richard Rothstein, MD; Dartmouth-Hitchcock Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Abrams JA, Komanduri S, Shaheen NJ, Wang Z, Rothstein RI. Radiofrequency ablation for the treatment of weight regain after Roux-en-Y gastric bypass surgery. Gastrointest Endosc. 2018 Jan;87(1):275-279.e2. doi: 10.1016/j.gie.2017.06.030. Epub 2017 Jul 13.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT01910688
• Other Study ID Numbers: B-600
• First Posted: July 30, 2013
• Results First Posted: June 24, 2016
• Last Update Posted: June 24, 2016
• Last Verified: June 2016

Keywords provided by Medtronic - MITG:

RGB Salvage, RFA