Comparing Reduction With ESD- Versus APC-TORe
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStephen Firkins
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 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
E-TORe
Procedure/SurgeryThe 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
Procedure/SurgeryThe 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: E-TOReExperimental treatment 1 intervention
Group B: c-TOReActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Weight change at 6 months
Percent total body weight change 6 months following TORe procedure
Time frame
6 months from procedure date2
Weight change at 12 months
Percent total body weight change 12 months following TORe procedure
Time frame
12 months from procedure dateSecondary outcomes
1
Technical success
Rates of technical success of the procedure as determined by the experienced endoscopist performing the TORe procedure
Time frame
Day of procedure2
Procedure time
Mean time to complete each procedure type
Time frame
Day of procedure3
Adverse event rate
Rate of adverse events related to each procedure type
Time frame
One year from date of procedure4
5% total body weight loss
Proportion of subjects who achieved at least 5% total body weight loss
Time frame
One year from date of procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stephen Firkins
Lead sponsor
The Cleveland Clinic
Sponsor institution
Source ClinicalTrials.gov