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Weight RegainREIGNITENCT07015424

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

A study testing TORe with OverStitch and Intensive lifestyle modification in people with Weight Regain and Weight Loss, run by Boston Scientific Corporation at 12 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Weight Regain, Weight Loss
What is being tested?
TORe with OverStitch and Intensive lifestyle modification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
12 sitesUnited States
Study dates
14 Apr 2026to Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Victoria Lazzari contact

508-561-7296

victoria.lazzari@bsci.com

12 sites in 1 country

United States12 sites, 12 recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Margaret "Geri" Keane, MD

    Not yet recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Amanda Lin, amanda_f_lin@rush.edu

    Christopher Chapman, MD

    Recruiting

  • University of Texas Houston Health Science Center

    Houston, Texas, 77030

    Angielyn Rivera, Angielyn.r.rivera@uth.tmc.edu

    Erik Wilson, MD

    Recruiting

  • Hoag Memorial Hospital

    Irvine, California, 92618

    Laurie Hendricks, laurie.hendricks@hoag.org

    Jennifer Phan, MD

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Kim Hall, Hall.Kimberly@mayo.edu

    Victoria Gomez, MD

    Recruiting

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506

    Shailendra Singh, MD

    Not yet recruiting

  • NYU Grossman School of Medicine

    New York, New York, 10016

    Valeria Pasuizaca, valeria.pasuizaca-yanez@nyulangone.org

    Rabia De Latour, MD

    Recruiting

  • Northwell Health

    New York, New York, 10075

    Steven Shamah, MD

    Not yet recruiting

  • Orlando Health Inc

    Orlando, Florida, 32806

    Leticia Morales, Leticia.Morales@orlandohealth.com

    Andre Teixeira, MD

    Recruiting

  • Mayo Clinic Foundation

    Rochester, Minnesota, 55905

    Liz Lemke, lemke.elizabeth@mayo.edu

    Eric J Vargas Valls, MD

    Recruiting

  • Stanford University Medical Center

    Stanford, California, 94305

    Micaela Esquivel, mesquive@stanford.edu

    Micaela Esquivel, MD

    Recruiting

  • University of South Florida

    Tampa, Florida, 33606

    Avennette Pinto, apinto3@usf.edu

    Salvatore Docimo, DO

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
TORe with OverStitch, Intensive lifestyle modification
Keywords
TORe, OverStitch
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TORe with OverStitchDevice

    Transoral Outlet Reduction with OverStitch Endoscopic Suturing System

  • Intensive lifestyle modificationBehavioural

    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.

Study groups in NCT07015424
Study groupRoleWhat they receive
TORe and Lifestyle Modification ArmActive comparatorSubjects will receive a TORe procedure and moderate to intensive lifestyle modification throughout the study
Receives: Device: TORe with OverStitch; Behavioral: Intensive lifestyle modification
Lifestyle Modification ArmActive comparatorSubjects will receive moderate to intensive lifestyle modification throughout the study. At 6 months post enrollment, subjects will be eligible to receive a TORe procedure.
Receives: Behavioral: Intensive lifestyle modification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Body Weight Loss

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

    Measured: 6 Months post enrollment

Secondary outcomes (20)

  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.

    Measured: 6, 12 and 24 months post enrollment

  2. Percent TBWL at each visit

    Percent TBWL at each visit

    Measured: 6 months post enrollment and through end of study

  3. Change in A1C

    Change in Hemoglobin A1C from baseline

    Measured: 6, 12, 18, and 24 months post enrollment

  4. Change in Insulin

    Change in Insulin from baseline

    Measured: 6, 12, 18, and 24 months post enrollment

  5. Change in Fasting Glucose

    Change in Fasting Glucose from baseline

    Measured: 6, 12, 18, and 24 months post enrollment

  6. Change in Cholesterol

    Change in Total Cholesterol from baseline

    Measured: 6, 12, 18, and 24 months post enrollment

  7. Change in LDL

    Change in LDL from baseline

    Measured: 6, 12, 18, and 24 months post enrollment

  8. Change in HDL

    Change in HDL from baseline

    Measured: 6, 12, 18, and 24 months post enrollment

  9. Change in Triglycerides

    Change in Triglycerides from baseline

    Measured: 6, 12, 18, and 24 months post enrollment

  10. Change in Alanine transaminase (ALT)

    Change in ALT from baseline

    Measured: 6, 12, 18, and 24 months post enrollment

  11. Change in Alkaline phosphatase (ALP)

    Change in ALP from baseline

    Measured: 6, 12, 18, and 24 months post enrollment

  12. Change in Aspartate aminotransferase (AST)

    Change in AST from baseline

    Measured: 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

    Measured: 6, 12, 18 and 24 months post enrollment

  14. Reduction in Hypertension Medication

    Reduction in hypertension medication dose and frequency from Baseline

    Measured: 6, 12, 18 and 24 months post enrollment

  15. Reduction in cholesterol medication

    Reduction in cholesterol medication dose and frequency from Baseline

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 6, 12, 18, and 24 months post enrollment

  20. Change in Sigstad Score

    Change in Sigstad score from baseline

    Measured: 6, 12, 18, and 24 months post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start14 Apr 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015424
Sponsor's protocol ID
E7220
Acronym
REIGNITE
Status last verified
Oct 2026
First submitted
21 May 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing TORe with OverStitch and Intensive lifestyle modification in people with Weight Regain and Weight Loss, run by Boston Scientific Corporation at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Victoria Lazzari (508-561-7296, victoria.lazzari@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Body Weight Loss (time frame: 6 Months post enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07015424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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