TORe + Lifestyle Changes for Weight Regain

(REIGNITE Trial)

Not yet recruiting at 9 trial locations

Overseen By Andrea Burbage

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must be taking: Anti-diabetic

Must not be taking: Weight loss supplements

Disqualifiers: Pregnancy, Breastfeeding, Vulnerable, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a procedure called TORe (Transoral Outlet Reduction), combined with lifestyle changes, in helping individuals lose weight regained after gastric bypass surgery. It compares two groups: one receiving only lifestyle coaching and the other receiving both the TORe procedure and lifestyle coaching. Individuals who have regained at least 20% of their lowest weight after surgery and are open to the TORe procedure may be suitable candidates. Participants will follow a calorie-restricted diet, an exercise plan, and receive lifestyle coaching, with some having the opportunity to undergo the TORe procedure. The study will monitor participants' progress over 24 months. As an unphased trial, this study provides a unique opportunity to explore innovative weight loss solutions after gastric bypass surgery.

Will I have to stop taking my current medications?

You can continue taking your current medications, but you must not take any additional weight loss supplements or medications during the first 6 months of the study. If you are on anti-diabetic medication, you need to be on a stable dose for three months with no changes expected during the first 6 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the TORe procedure is generally safe for individuals who have regained weight after gastric bypass surgery. Studies indicate that TORe aids in weight loss and is well-tolerated by patients. One study demonstrated significant weight loss, with positive outcomes persisting even seven years later. A review of 1,154 patients found an average weight loss of about 8.9% in the first year following the procedure.

These findings suggest that TORe is a safe option for those needing assistance with weight regain after their initial surgery. Notably, these studies reported no major safety concerns, which is encouraging for those considering the procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TORe (Transoral Outlet Reduction) treatment for weight regain after bariatric surgery because it offers a minimally invasive approach to address this common issue. Unlike traditional surgical revisions, which can be more invasive and carry higher risks, TORe is performed endoscopically, meaning it is less invasive and typically involves a shorter recovery time. Additionally, when combined with intensive lifestyle modifications, TORe has the potential to enhance weight loss outcomes more effectively than lifestyle changes alone. This combination approach aims to provide a more comprehensive solution to managing weight regain, encouraging better long-term results.

What evidence suggests that this trial's treatments could be effective for weight regain?

Research has shown that the TORe procedure can help manage weight gain after Roux-en-Y gastric bypass surgery. In this trial, one group of participants will receive the TORe procedure along with intensive lifestyle modification. Studies have found that patients undergoing the TORe procedure lost about 8.9% of their total weight after 12 months. This weight loss tends to persist, with similar results observed at 1, 3, and 5 years. The procedure is generally safe and effective. Specifically, one study found that for every 1.3 people treated, one person benefits significantly. These findings suggest that TORe can be a useful option for managing weight regain. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have regained weight after a Roux-en-Y gastric bypass. Participants should be committed to lifestyle changes and willing to follow a calorie-restricted diet, exercise regularly, and engage in coaching sessions. Specific eligibility criteria are not provided.

Inclusion Criteria

GJA diameter ≥ 20 mm, confirmed either during a Screening EGD completed ≤ 30 days from study procedure or EGD performed immediately prior to the TORe procedure

I agree not to take any weight loss supplements or medications for the first 6 months of the study.

Agrees to the follow-up requirements of the study and is able to read, understand, and sign a written Informed Consent Form to participate in the study

Exclusion Criteria

Investigator's medical judgement that the subject is not a candidate for the TORe procedure

I am managing my Type 2 Diabetes with incretin-based medication.

I haven't taken any weight loss drugs or supplements in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a TORe procedure with intensive lifestyle modification or intensive lifestyle modification alone

6 months

Regular visits for lifestyle coaching and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Visits at 6, 12, 18, and 24 months post enrollment

Open-label extension (optional)

Participants in the lifestyle modification alone arm may opt to receive a TORe procedure at 6 months

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• TORe

Trial Overview The study compares two approaches: TORe (Transoral Outlet Reduction) with OverStitch plus intensive lifestyle modifications versus just the lifestyle changes alone. Two-thirds of participants will receive both TORe and lifestyle interventions; the rest will start with only lifestyle changes but can opt for TORe after six months.

How Is the Trial Designed?

Group I: Lifestyle Modification Arm Active Control 1 Intervention

Subjects will receive intensive lifestyle modification throughout the study. At 6 months post enrollment, subjects will be eligible to receive a TORe procedure.

Group II: TORe and Lifestyle Modification Arm Active Control 2 Interventions

Subjects will receive a TORe procedure and intensive lifestyle modification throughout the study

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Citations

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

Long-term results after transoral outlet reduction (TORe) of ... Mean time between bariatric surgery and TORe was 80.0 ± 45.6 months: 77.7 ± 45.0 months in the weight regain group, 65.9 ± 36.6 months in the ...

2. giejournal.org giejournal.org/article/S0016-5107(20)31523-6/fulltext

Sa1938 SEVEN YEAR OUTCOMES OF TRANSORAL ... TORe appears safe, effective and durable at treating weight regain following RYGB, with a NNT of 1.3. The amount of weight loss at 1 year predicts 7-year ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510725017006

Association for Bariatric Endoscopy systematic review and ... At 12 months post-TORe, the pooled total weight loss (TWL) across 12 studies (1154 patients) was 8.9% (95% confidence interval [CI], 6.5%-11.3%; ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31816315/

Five-year outcomes of transoral outlet reduction for ... - PubMed Patients experienced 8.5% ± 8.5%, 6.9% ± 10.1%, and 8.8% ± 12.5% total weight loss (TWL) at 1, 3, and 5 years with follow-up rates of 83.3%, 81.8%, and 82.9%, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07015424

Randomized Study on Transoral Outlet Reduction and ... Experiencing weight regain (≥ 20% weight from nadir) after achieving clinically successful weight loss. Willing to have a TORe procedure for the treatment of ...

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

Long-term Outcomes of Transoral Outlet Reduction (TORe) ... The aim of this study is to assess the safety and long-term efficacy of endoscopic transoral outlet reduction (TORe) for DS and/or weight regain ...

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

Comparing Outcomes of Classic Transoral The c-TORe is the most widely employed endoscopic revision, however recent limited data demonstrates increased weight loss following E-TORe compared to c-TORe,.

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

Long-term results after transoral outlet reduction (TORe) of ... Outcome of endoscopic procedure​​ Mean time between bariatric surgery and TORe was 80.0 ± 45.6 months: 77.7 ± 45.0 months in the weight regain ...