An interventional study of E-TORe and c-TORe in Obesity, Roux-en-y Anastomosis Site and Weight Gain, sponsored by Stephen Firkins. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Stephen Firkins · Not applicable, Interventional, and Treatment
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:
Weight regain after having a Roux-en-Y gastric bypass is common. One of the primary reasons for weight regain after bypass is stretching out or "dilation" of the surgical connection created between what is left of the stomach and the small intestine (called the anastamosis). As the ability to suture with the help of a scope inserted through the mouth into the stomach instead of surgery, the transoral outlet reduction (TORe) was developed. The TORe involves suturing around the stretched out anastamosis, allowing it to be pulled tighter and shrink down, resulting in weight loss, and is an entirely endoscopic and reversible procedure. As the procedure advanced, "burning" of the stomach lining using a technique called argon plasma coagulation (APC), in addition to suturing, became the standard way to perform the TORe procedure. The APC helps the stomach tissue shrink even more and heal into place better, causing even more weight loss. This is now the classic way to perform the TORe (hereby called the "c-TORe"), and is now widely used to help patients who have regained weight after gastric bypass.
Multiple studies report the c-TORe results in an average of 8-9% total body weight loss. However more recently, another variation of the TORe was developed, which uses endoscopic submucosal dissection (ESD). In the ESD-TORe (hereby called the E-TORe), the physician makes a small cut in the surface layer of the anastamosis in addition to APC and suturing. In the only study comparing c-TORe to E-TORe, E-TORe resulted in significantly more weight loss. However, there are several limitations to this study that require more investigation.
This clinical trial will compare the c-TORe and the E-TORe. Patients who are eligible and willing to undergo a TORe procedure will be assigned to get either the c-TORe or the E-TORe. They will undergo the procedure with a physician experienced in both types of the procedure. Participants will be followed for one year after the procedure to compare which procedure type results in more weight loss.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 70 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Stephen Firkins is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm received the E-TORe procedure
Procedure: E-TORe
Participants in this arm received the "classical" or c-TORe procedure
Procedure: c-TORe
The 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.
Also known as: ESD-TORe, endoscopic submucosal dissection TORe
The 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.
Also known as: classic TORe, APC-TORe, argon plasma coagulation TORe
Weight change at 6 months
Percent total body weight change 6 months following TORe procedure
Time frame: 6 months from procedure date
Weight change at 12 months
Percent total body weight change 12 months following TORe procedure
Time frame: 12 months from procedure date
Technical success
Rates of technical success of the procedure as determined by the experienced endoscopist performing the TORe procedure
Time frame: Day of procedure
Procedure time
Mean time to complete each procedure type
Time frame: Day of procedure
Adverse event rate
Rate of adverse events related to each procedure type
Time frame: One year from date of procedure
5% total body weight loss
Proportion of subjects who achieved at least 5% total body weight loss
Time frame: One year from date of procedure
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Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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