Transoral Outlet Reduction for Weight Gain After Surgery

Comparing Reduction With ESD- Versus APC-TORe

Recruiting N/A Interventional Study
Obesity Roux-en-y Anastomosis Site Weight Gain
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Stephen Firkins · Other
Who this trial is looking for

This trial is looking for adults who have gained weight after Roux-en-Y gastric bypass surgery. Participants will undergo a new weight loss procedure called Transoral Outlet Reduction, and doctors will compare two different methods to see which one works better and is safer.

Are You a Good Fit for This Trial?
Rules you out Insulin-dependent diabetes mellitus

You may be able to join if

  • I have a history of Roux-en-Y gastric bypass and have regained weight.
  • I have a dilated gastrojejunal anastomosis diagnosed by endoscopy.
  • I am enrolled in the GI Bariatric Endoscopy program at the study site.

You may not be able to join if

  • I have had a revision of my gastric bypass.
  • I have active and uncontrolled gastro-esophageal reflux disease.
  • I have an active untreated Helicobacter pylori infection.
  • I have a newly diagnosed malignancy shown by endoscopy.
  • I have upper gastrointestinal issues that prevent the procedure.
  • I cannot undergo general anesthesia.
  • I am currently pregnant.
  • I cannot stop taking anticoagulation therapy.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 a…
Trial Locations
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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…
Contacts

Stephen Firkins, MD

2164448460

bariatricendoscopy@ccf.org

CONTACT