ESD-TORe vs APC-TORe for Obesity After Gastric Bypass

(CREATORe Trial)

Overseen By Stephen Firkins, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carlos Roberto Simons-Linares

Must not be taking: Anticoagulants, P2Y12 inhibitors

Disqualifiers: Prior revision, Uncontrolled reflux, Pregnancy, Insulin-dependent diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day of procedure

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to help individuals lose weight after experiencing weight regain following a gastric bypass. It compares two types of Transoral Outlet Reduction (TORe) to determine which is more effective and safer for weight loss. Individuals who have undergone a Roux-en-Y gastric bypass, are regaining weight, and have a widened connection between their stomach and small intestine may be suitable for this study. Participants will receive either the classic TORe procedure (c-TORe) or a new version called APC-TORe, with all other care remaining consistent. The goal is to identify which method is more effective and safer for patients. As an unphased trial, this study allows participants to contribute to innovative research that could enhance weight loss outcomes for many.

Will I have to stop taking my current medications?

The trial requires that participants stop using anticoagulation therapy or P2Y12 inhibitors around the time of the procedure. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

What prior data suggests that the TORe procedure is safe for patients with a history of gastric bypass?

Research has shown that the Transoral Outlet Reduction (TORe) procedure is generally safe for individuals who have regained weight after gastric bypass surgery. Both E-TORe and c-TORe versions are well-tolerated and effective for weight management.

For the E-TORe procedure, studies highlight its safety and long-term success. One study noted that TORe has a good safety record, with positive results even five years post-procedure, indicating patients did not experience major complications over time. Another study confirmed its safety, particularly when performed by experienced doctors.

Similarly, the c-TORe procedure also maintains a strong safety record. It is often performed in outpatient settings, allowing patients to avoid overnight hospital stays. Experts state it is safer than undergoing another surgery to address weight regain.

Overall, both TORe variations are designed to be safe and assist in managing weight regain after gastric bypass surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the E-TORe and c-TORe procedures for obesity following gastric bypass because they offer new approaches to manage weight regain. Unlike traditional methods that may rely on lifestyle changes or medications, these procedures directly modify the gastrointestinal anatomy to enhance weight loss. The E-TORe procedure is particularly intriguing as it employs endoscopic suturing, which may provide a less invasive option compared to more extensive surgeries. Meanwhile, the c-TORe, or classical TORe, is an active comparator that represents the established approach, allowing researchers to gauge the potential improvements offered by E-TORe. These innovations could lead to more effective and less invasive solutions for those struggling with weight regain after gastric bypass surgery.

What evidence suggests that this trial's procedures could be effective for weight loss after gastric bypass?

This trial will compare two methods of the Transoral Outlet Reduction (TORe) procedure for managing weight regain after gastric bypass surgery: E-TORe and c-TORe. Research has shown that the E-TORe method can help people maintain weight loss, with one study finding that 84% of patients kept the weight off for several years. Another study confirmed that E-TORe is safe and effective for long-term weight control. Meanwhile, the c-TORe method has consistently helped participants lose about 8-9% of their total body weight. Both methods effectively manage weight regain after gastric bypass surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Stephen Firkins, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults who had Roux-en-Y gastric bypass surgery but gained weight back. They must have a widened gastrojejunal connection seen on endoscopy and be getting standard obesity care at the study's GI Bariatric Endoscopy program.

Inclusion Criteria

I am receiving TORe for obesity as part of the GI Bariatric Endoscopy program.

I had Roux-en-Y gastric bypass surgery and have regained weight.

My stomach connection to the small intestine is enlarged.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the c-TORe or E-TORe procedure to assist with weight loss

Day of procedure

1 visit (in-person)

Follow-up

Participants are monitored for weight change and adverse events after the procedure

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• c-TORe
• E-TORe

Trial Overview The trial compares two ways of doing the TORe procedure to see which one leads to more weight loss and is safer. Participants will randomly receive either c-TORe or E-TORe, with all other aspects of care being identical.

How Is the Trial Designed?

Group I: E-TORe Experimental Treatment 1 Intervention

Participants in this arm received the E-TORe procedure

Group II: c-TORe Active Control 1 Intervention

Participants in this arm received the "classical" or c-TORe procedure

c-TORe is already approved in United States, European Union for the following indications:

Approved in United States as Transoral Outlet Reduction for:

• Weight regain after Roux-en-Y gastric bypass surgery

Approved in European Union as TORe for:

• Weight regain after gastric bypass surgery

Who Is Running the Clinical Trial?

Carlos Roberto Simons-Linares

Lead Sponsor

Trials

2

Recruited

190+

Stephen Firkins

Lead Sponsor

Published Research Related to This Trial

Transoral outlet reduction (TORe) is a safe and effective procedure for managing weight regain after Roux-en-Y Gastric Bypass (RYGB), particularly in patients with genetic variants.

In a study of 14 patients, those with a heterozygous variant in the leptin melanocortin pathway (LMP) lost significantly less weight after TORe compared to non-carriers, indicating that genetic factors may influence the efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Heterozygous Variants in the Leptin-Melanocortin Pathway on Transoral Outlet Reduction After Roux-en-Y Gastric Bypass: A Case-Control Study and Review of Literature. Gala, K., Ghusn, W., Fansa, S., et al.[2023]

Purse-string transoral outlet reduction (TORe) is a technically feasible and safe procedure for patients who have regained weight after Roux-en-Y gastric bypass, with a 100% technical success rate in 260 procedures.

Patients experienced significant weight loss, averaging 9.6% at 6 months and 8.4% at 12 months, along with improvements in metabolic health markers such as blood pressure and hemoglobin A1c.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Purse-string transoral outlet reduction (TORe) is effective at inducing weight loss and improvement in metabolic comorbidities after Roux-en-Y gastric bypass. Jirapinyo, P., Kröner, PT., Thompson, CC.[2022]

Both full-thickness suturing plus argon plasma mucosal coagulation (ft-TORe) and argon plasma mucosal coagulation alone (APMC-TORe) are effective in achieving significant weight loss after Roux-en-Y gastric bypass, with comparable results at 3, 6, and 12 months.

The safety profiles of both techniques are high, with only one severe adverse event reported for APMC-TORe and none for ft-TORe, indicating that both methods are safe options for managing weight regain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic full-thickness suturing plus argon plasma mucosal coagulation versus argon plasma mucosal coagulation alone for weight regain after gastric bypass: a systematic review and meta-analysis. Jaruvongvanich, V., Vantanasiri, K., Laoveeravat, P., et al.[2021]

Transoral outlet reduction (TORe) is a safe and effective procedure for adults experiencing weight recurrence after Roux-en-Y gastric bypass, showing a total body weight loss of 17.3% at twelve months in a study of 284 patients.

The procedure had a low complication rate, with only 3.9% of patients experiencing outlet stenosis, which was successfully treated, and a serious adverse event rate of just 0.4%, indicating good safety in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transoral outlet reduction: Outcomes of endoscopic Roux-en-Y gastric bypass revision in 284 patients at a community practice. Maselli, DB., Chittajallu, V., Wooley, C., et al.[2023]

In a study of 29 patients who underwent transoral outlet reduction (TORe) after Roux-en-Y gastric bypass, significant weight regain occurred by the 3-year follow-up, with patients regaining all weight lost at 12 months and the gastrojejunostomy diameter returning to pre-procedure sizes.

Quality of life improvements observed at 12 months were mostly lost by the 3-year mark, indicating that TORe may need to be repeated over time to maintain its benefits, as only the energy/fatigue domain showed sustained improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up after transoral outlet reduction following Roux-en-Y gastric bypass: Back to stage 0? Brunaldi, VO., Peixoto de Oliveira, GH., Kerbage, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11289335/

Long-term results after transoral outlet reduction (TORe) of ... They reported a resolution rate of 88% and positive results of 84% remained even after a long-term follow-up of 3, 5 years on average.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10600692/

Transoral outlet reduction: Outcomes of endoscopic Roux- ... Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013;145:129–137.e3. doi ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/81/NCT06131281/Prot_SAP_000.pdf

Comparing Outcomes of Classic Transoral Thompson, C.C., et al., Endoscopic suturing for transoral outlet reduction increases weight loss after. Roux-en-Y gastric bypass surgery. Gastroenterology, 2013 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510719324952

Five-year outcomes of transoral outlet reduction for the ... This study demonstrates the safety, efficacy, and 5-year durability of TORe in patients with weight regain or inadequate weight loss after RYGB.

5. link.springer.com link.springer.com/article/10.1007/s11695-025-08275-9

Transoral Outlet Reduction for Dumping Syndrome After ... Our findings suggest that TORe is a safe and effective minimally invasive treatment for patients with medically refractory dumping syndrome.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10079715/

Long-term Outcomes of Transoral Outlet Reduction (TORe) ... Endoscopic trans-oral outlet reduction after bariatric surgery is safe and effective for dumping syndrome. Surg Endosc. 2021;35:6846–6852 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06131281

Comparing Reduction With ESD- Versus APC-TORe Researchers will compare outcomes between the two procedure variations, looking at which one results in more weight loss, is more successful, and safer.

8. link.springer.com link.springer.com/article/10.1007/s00464-024-10989-3

Long-term results after transoral outlet reduction (TORe) of ... They reported a resolution rate of 88% and positive results of 84% remained even after a long-term follow-up of 3, 5 years on average.