NCT01910688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

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, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 24, 2016

Completed
Last Updated

June 24, 2016

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

July 24, 2013

Results QC Date

April 27, 2016

Last Update Submit

June 2, 2016

Conditions

Obesity

Keywords

RGB Salvage, RFA

Outcome Measures

Primary Outcomes (1)

  • Excess Body Weight Loss After RFA Treatment

    EBWL 12 months after enrollment

    12 months

Secondary Outcomes (3)

  • Technical Feasibility: Percentage of Participants Who Completed RFA Treatment

    Day 0, month 4, month 8

  • Patient Tolerability

    12 months

  • Adverse Events

    12 months

Study Arms (1)

RFA treatment (Radiofrequency ablation)

EXPERIMENTAL

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

Interventions

RFA treatmentDEVICE

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.

Also known as: HALO60, HALO90, HALO90 Ultra
RFA treatment (Radiofrequency ablation)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Columbia Univeristy

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 28713063DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Julian Abrams
Organization
Columbia University Medical Center
ja660@cumc.columbia.edu
(212) 235-1496

Study Officials

  • Julian Abrams, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Richard Rothstein, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 30, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

June 24, 2016

Results First Posted

June 24, 2016

Record last verified: 2016-06

Locations

US(2)