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 outInsulin-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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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City
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Status
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…
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
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