Comparing Reduction With ESD- Versus APC-TORe (NCT06131281) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparing Reduction With ESD- Versus APC-TORe
United States70 participantsStarted 2023-10-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 compli…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.