Use of Radiofrequency Ablation for RGB Salvage

NCT ID: NCT01910688

Last Updated: 2016-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-01-31

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.

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RFA treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

HALO60, HALO90, HALO90 Ultra

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian Abrams, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Richard Rothstein, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Columbia Univeristy

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28713063 (View on PubMed)

Other Identifiers

B-600

Identifier Type: -

Identifier Source: org_study_id