Recruiting

ESD vs. APC-TORe

Sponsor:

Stephen Firkins

Code:

NCT06131281

Conditions

Obesity

Roux-en-y Anastomosis Site

Weight Gain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

E-TORe

c-TORe

Study Details

Brief summary:

The goal of this clinical trial is to compare two variations of the same procedure used to assist with weight loss in patients who have a history of Roux-en-Y gastric bypass who have experienced weight regain. The procedure being studied is called the Transoral Outlet Reduction (TORe), and the trial will compare two different ways to complete the TORe procedure. The main question\[s\] it aims to answer are:

  • Which variation of the TORe procedure results in more weight loss?
  • Which variation of the TORe is safer? Participants who are eligible and willing to undergo the TORe procedure to assist with weight loss will have the procedure completed either one of the two ways. All other care will be exactly the same between the two groups. Researchers will compare outcomes between the two procedure variations, looking at which one results in more weight loss, is more successful, and safer.

Conditions

Obesity

Roux-en-y Anastomosis Site

Weight Gain

Study ID

NCT06131281

Start date

Oct 2, 2023

Status verified date

Sep, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult patients with history of Roux-en-Y gastric bypass and weight regain
  • Dilated gastrojejunal anastamosis as diagnosed on endoscopy
  • Patients undergoing standard of care for treatment of obesity with endoscopic revisional procedure (a.k.a. TORe) who are enrolled in the GI Bariatric Endoscopy program and clinic at the study site

Exclusion Criteria:

  • Prior revision of gastric bypass
  • Active and uncontrolled gastro-esophageal reflux disease defined as ≥ grade C esophagitis
  • Active untreated Helicobacter pylori infection
  • Malignancy newly diagnosed by endoscopy
  • Upper gastro-intestinal conditions such as ulcers, polyps, gastric varices, strictures, congenital or acquired intestinal telangiectasia or other abnormalities that preclude completion of TORe
  • Presence of gastrogastric or gastroenteric fistula
  • Inability to undergo general anesthesia
  • Participating in another ongoing clinical trial of an investigational weight loss drug or device
  • Active pregnancy
  • Use of anticoagulation therapy or P2Y12 inhibitors which cannot be discontinued for the time frame surrounding the procedure
  • Insulin-dependent diabetes mellitus
  • Unwillingness to comply with standard post-TORe dietary guidelines and follow-up care
  • Any other anatomical, technical or otherwise factor that limits the ability of the endoscopist to perform either E-TORe or c-TORe
  • Any additional factor, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the trial protocol

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: E-TORe

Participants in this arm received the E-TORe procedure

active comparator: c-TORe

Participants in this arm received the "classical" or c-TORe procedure

Interventions

E-TORe

The E-TORe utilizes ESD in addition to APC prior to endoscopic suturing. In this approach, a standardized solution of normal saline or hetastarch mixed with methylene blue and epinephrine is injected into the gastric rim of the GJA outlet. The mucosa is then carefully incised to expose the underlying muscular layer for a width of approximately 1cm around the GJA circumference. Following ESD, APC is then applied to the inner and outer mucosal margins of the ESD tract. Finally, endoscopic sutures are then placed in purse string fashion and cinched closed around a 6mm TTS balloon.

c-TORe

The c-TORe will be completed utilizing APC prior to endoscopic suturing. In this approach, the gastric rim of the anastomosis is circumferentially ablated using APC (forced APC, flow of 0.8 L/min and power of 30-70 watts) extending an average of 1-2 cm from the outlet. Following ablation, endoscopic sutures are placed in a purse string fashion within the ablated area and the outlet cinched closed over a 6mm through-the scope (TTS) balloon.

Primary outcome measure

  • Weight change at 6 months [ Time Frame: 6 months from procedure date ]
  • Weight change at 12 months [ Time Frame: 12 months from procedure date ]

Central Contacts and Locations

Central contacts

Stephen Firkins, MD

2164448460bariatricendoscopy@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Ste Firkins, MD

2164448460bariatricendoscopy@ccf.org

More Information

Sponsor

Stephen Firkins

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Stephen Firkins on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.