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Comparing Reduction With ESD- Versus APC-TORe

Comparing Outcomes of Classic Transoral Outlet Reduction (TORe) Versus Endoscopic Submucosal Dissection-TORe: A Randomized Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be followed for one year after the procedure to compare which procedure type results in more weight loss."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two ways to do TORe, a procedure to help with weight loss. It is for adults who have regained weight after Roux-en-Y gastric bypass surgery. Researchers want to learn which way leads to more weight loss, works better, and is safer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult who has regained weight after Roux-en-Y gastric bypass surgery.
  • The opening between your stomach pouch and small intestine is enlarged, as shown by a camera exam called an endoscopy.
  • You are in the study site's GI Bariatric Endoscopy program and clinic and are getting TORe as part of your usual obesity care.

Who can't join

  • You have already had a procedure to revise your gastric bypass.
  • You have uncontrolled acid reflux with severe swelling or damage in the food pipe (grade C or higher), an untreated H. pylori stomach infection, or cancer newly found during an endoscopy.
  • You have ulcers, growths, swollen veins, narrow areas, abnormal blood vessels, or other digestive tract problems that prevent TORe. This includes an abnormal passage between parts of the stomach or between the stomach and intestine.
  • You cannot have general anesthesia, which puts you to sleep for the procedure, or you are pregnant.
  • You take blood-thinning medicine that cannot be stopped around the procedure, or you have diabetes that requires insulin.
  • You are in another ongoing study of an experimental weight-loss drug or device.
  • You are not willing to follow the usual diet rules and follow-up care after TORe.
  • Another issue prevents the doctor from doing either version of TORe, or the study doctor believes an issue could put your safety or ability to follow study rules at risk.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

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