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NCT Number: NCT07015424

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

The goal of this clinical trial is to evaluate weight loss with TORe and intensive lifestyle modification versus 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 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.

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Key information

Conditions

Weight Regain Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hoag Memorial Hospital, Irvine, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • BMI 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 Informed Consent Form to participate in the study.
  • Meets the indications for TORe procedure with OverStitch™ Endoscopic Suturing System.

Exclusion criteria

  • Current use or use within the three months prior to the baseline visit of over the counter or prescribed weight loss supplements / medications (including incretins).
  • Current or planned management of Type 2 Diabetes 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.

Treatment and study plan

TORe with OverStitch

Device

Transoral Outlet Reduction with OverStitch Endoscopic Suturing System

Intensive Lifestyle Modification

Behavioral

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.

Primary outcomes

  1. Total Body Weight Loss

    Time frame: 6 Months post enrollment

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

Secondary outcomes

  1. Clinically significant weight loss

    Time frame: 6, 12 and 24 months post enrollment

    The rate of subjects that achieve clinically significant weight loss (i.e. responders) at 6 months. Clinically significant weight loss is defined as ≥ 10% TBWL.

  2. Percent TBWL at each visit

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

    Percent TBWL at each visit

  3. Change in A1C

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

    Change in Hemoglobin A1C from baseline

  4. Change in Insulin

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

    Change in Insulin from baseline

  5. Change in Fasting Glucose

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

    Change in Fasting Glucose from baseline

  6. Change in Cholesterol

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

    Change in Total Cholesterol from baseline

  7. Change in LDL

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

    Change in LDL from baseline

  8. Change in HDL

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

    Change in HDL from baseline

  9. Change in Triglycerides

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

    Change in Triglycerides from baseline

  10. Change in Alanine transaminase (ALT)

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

    Change in ALT from baseline

  11. Change in Alkaline phosphatase (ALP)

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

    Change in ALP from baseline

  12. Change in Aspartate aminotransferase (AST)

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

    Change in AST from baseline

  13. Reduction in Medications for Type 2 diabetes

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

    Reduction in Type 2 diabetes medication dose and frequency from Baseline

  14. Reduction in Hypertension Medication

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

    Reduction in hypertension medication dose and frequency from Baseline

  15. Reduction in cholesterol medication

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

    Reduction in cholesterol medication dose and frequency from Baseline

  16. Reduction in medications for dumping syndrome

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

    Reduction in dumping syndrome medication dose and frequency from Baseline

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

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

    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.

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

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

    Change in IWQOL LITE-CT scores from baseline

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

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

    Change in SF-36 Questionnaire scores from baseline

  20. Change in Sigstad Score

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

    Change in Sigstad score from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria Lazzari

CONTACT

[email protected]

508-561-7296

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Prospective, Randomized Clinical Study Evaluating Transoral Outlet Reduction (TORe) and Lifestyle Modification for Patients With Weight Regain Following Roux-en-Y Gastric Bypass

Acronym: REIGNITE

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jun 11, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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