ClinicalTrials.gg
Sign In
RecruitingNCT07015424REIGNITEUpdated Oct 13, 2026

Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass

An interventional study of TORe with OverStitch and Intensive lifestyle modification in Weight Regain and Weight Loss, sponsored by Boston Scientific Corporation. Recruiting at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Oct 13, 2026Site recruiting status changedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate weight loss with TORe and moderate to intensive lifestyle modification versus moderate to intensive lifestyle modification alone in subjects who have regained weight following a Roux-en-Y gastric bypass.

Participants will randomized 2:1. Those randomized to the TORe arm will receive a TORe procedure and moderate to intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. Participants randomized the lifestyle modification alone arm will be eligible to receive a TORe procedure at 6 months post enrollment. Total follow up will be 24 months.

02

Conditions studied

  • Weight Regain
  • Weight Loss

Browse trials for

Keywords

  • TORe
  • OverStitch
03

In context

Weight Loss

1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.

This study's planned enrollment of 108 is above the median of 80 across 1,561 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Browse Boston Scientific Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 13, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years or older.
  • Experiencing weight regain (≥ 20% weight from nadir) after achieving clinically successful weight loss.
  • Willing to have a TORe procedure for the treatment of weight regain.
  • between 30 and 50 kg/m2, inclusive.
  • GJA diameter ≥ 20 mm, confirmed either during a
  • Screening EGD completed ≤ 60 days from study procedure or
  • EGD performed immediately prior to the TORe procedure.
  • Anatomically accepting of the procedure, including a pouch size that will not require reduction at the time of treatment (pouch that is shorter than 6 cm in length).
  • Agrees not to take additional over the counter or prescribed weight loss supplements / medications (including incretins) during the first 6 months of the study.
  • Is on a stable dose of anti-diabetic medication for three months with no anticipated changes during 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 Form to participate in the study.
  • Meets the indications for TORe procedure with OverStitch™ Endoscopic Suturing System.

Exclusion criteria

Exclusion Criteria:

  • Current use or use within the three months prior to the treatment visit of over the counter or prescribed weight loss supplements / medications (including incretins).
  • Current or planned management of any obesity-related comorbidity with incretin medications.
  • Inability or unwillingness to comply with assigned treatment or protocol requirements related to visits.
  • Investigator's medical judgement that the subject is not a candidate for the TORe procedure.
  • Current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding in the next two years.
  • Vulnerable subject.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (estimated)

Study arms

  • Active comparator
    TORe and Lifestyle Modification Arm

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

    Device: TORe with OverStitch · Behavioral: Intensive lifestyle modification

  • Active comparator
    Lifestyle Modification Arm

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

    Behavioral: Intensive lifestyle modification

Interventions

  • DeviceTORe with OverStitch

    Transoral Outlet Reduction with OverStitch Endoscopic Suturing System

  • BehavioralIntensive lifestyle modification

    Moderate to intensive lifestyle modification program consists of the following: well-balanced calorie-restrictive diet, incorporation of exercise and coaching on lifestyle changes. The program should include personal discussions and goals designed and overseen by the treating physician, obesity management professional or dietician.

06

What researchers measure

Primary outcomes

  1. Total Body Weight Loss

    The percent TBWL that subjects achieve at 6 months post-randomization

    Time frame: 6 Months post enrollment

Secondary outcomes

  1. Clinically significant weight loss

    The rate of subjects that achieve clinically significant weight loss (i.e. responders) at 6 months. Clinically significant weight loss is defined as ≥ 5% TBWL.

    Time frame: 6, 12 and 24 months post enrollment

  2. Percent TBWL at each visit

    Percent TBWL at each visit

    Time frame: 6 months post enrollment and through end of study

  3. Change in A1C

    Change in Hemoglobin A1C from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  4. Change in Insulin

    Change in Insulin from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  5. Change in Fasting Glucose

    Change in Fasting Glucose from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  6. Change in Cholesterol

    Change in Total Cholesterol from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  7. Change in LDL

    Change in LDL from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  8. Change in HDL

    Change in HDL from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  9. Change in Triglycerides

    Change in Triglycerides from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  10. Change in Alanine transaminase (ALT)

    Change in ALT from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  11. Change in Alkaline phosphatase (ALP)

    Change in ALP from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  12. Change in Aspartate aminotransferase (AST)

    Change in AST from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  13. Reduction in Medications for Type 2 diabetes

    Reduction in Type 2 diabetes medication dose and frequency from Baseline

    Time frame: 6, 12, 18 and 24 months post enrollment

  14. Reduction in Hypertension Medication

    Reduction in hypertension medication dose and frequency from Baseline

    Time frame: 6, 12, 18 and 24 months post enrollment

  15. Reduction in cholesterol medication

    Reduction in cholesterol medication dose and frequency from Baseline

    Time frame: 6, 12, 18 and 24 months post enrollment

  16. Reduction in medications for dumping syndrome

    Reduction in dumping syndrome medication dose and frequency from Baseline

    Time frame: 6, 12, 18 and 24 months post enrollment

  17. Number of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Continuous assessment of safety of TORe by summarizing the occurrence of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs) at all visits and overall.

    Time frame: From enrollment through 24 months (study completion)

  18. Change in Impact of Weight on Quality of Life (IWQOL LITE-CT) Quality of Life Questionnaire

    Change in IWQOL LITE-CT scores from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  19. Change in 36-Item Short Form Survey (SF-36) Quality of Life Questionnaire

    Change in SF-36 Questionnaire scores from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

  20. Change in Sigstad Score

    Change in Sigstad score from baseline

    Time frame: 6, 12, 18, and 24 months post enrollment

07

Study locations

9 of 12 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Sites
Rush University Medical Center is now Recruiting
Oct 13, 2026
Primary completion
Nov 2026→Jul 2027
Oct 13, 2026
Study completion
Nov 2028→Jul 2029
Oct 13, 2026
Eligibility
2 exclusion criteria edited
What changed in the criteria
Exclusion criteria
  • EditedCurrent use or use within the three months prior to the baselinetreatment visit of over the counter or prescribed weight loss supplements / medications (including incretins).
  • EditedCurrent or planned management of Type 2 Diabetesany obesity-related comorbidity with incretin medications.
Oct 13, 2026
Secondary outcomes
1 description edited
What changed in the outcomes
  • DescriptionClinically significant weight loss: how it is measured was reworded
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Rush University Medical Center is now Recruiting
    Primary completion Nov 2026→Jul 2027
    Study completion Nov 2028→Jul 2029
    Eligibility 2 exclusion criteria edited
    What changed in the criteria
    Exclusion criteria
    • EditedCurrent use or use within the three months prior to the baselinetreatment visit of over the counter or prescribed weight loss supplements / medications (including incretins).
    • EditedCurrent or planned management of Type 2 Diabetesany obesity-related comorbidity with incretin medications.
    Secondary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionClinically significant weight loss: how it is measured was reworded
    + 3 other changes: verification date, description and arm descriptions

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 ↗

09

Registry details

Key details

Study ID
NCT07015424
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Jun 11, 2025
Start date
Apr 14, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2029 (estimated)
Last update
Oct 13, 2026

Study contacts

Victoria Lazzari
Contact
victoria.lazzari@bsci.com
508-561-7296

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Weight Loss →

Other studies from this sponsor

Boston Scientific Corporation →

Start the discussion