Last reviewed · How we verify
NCT07015424: REIGNITE
Prospective, Randomized Clinical Study Evaluating Transoral Outlet Reduction (TORe) and Lifestyle Modification for Patients With Weight Regain Following Roux-en-Y Gastric Bypass
NA trial testing TORe with OverStitch in Weight Regain in 108 participants. Currently enrolling.
1 November 2026
Quick facts
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 14 April 2026 |
| Primary completion | 1 November 2026 |
| Estimated completion | 1 November 2028 |
| Sites | 9 locations across United States |
Drugs / interventions tested
- TORe with OverStitch
- Intensive lifestyle modification
Conditions studied
- Weight Regain — all drugs for Weight Regain →
- Weight Loss — all drugs for Weight Loss →
Sponsor
Boston Scientific Corporation — full company profile →
Who can join
18 and older, any sex, with Weight Regain or Weight Loss. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Total Body Weight Loss
Time frame: 6 Months post enrollment
The percent TBWL that subjects achieve at 6 months post-randomization
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07015424
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Weight Regain
Currently open trials in the same condition.
- NCT06801496 — The Application of Gastric Bypass Stents in Patients with Weight Regain After Laparoscopic Sleeve Gastrectomy：a Feasibil · recruiting
- NCT04832282 — Napoleon Measurement of Gastrojejunal Anastomosis · NA · active not recruiting
Other Boston Scientific Corporation trials
Trials by the same sponsor.
- NCT07458243 — Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT · not yet recruiting
- NCT07458217 — Combined CM and STN Stimulation for Motor Epilepsy · NA · not yet recruiting
- NCT07276815 — OverStitch NXT Endoscopic Suture System · NA · not yet recruiting
- NCT07353710 — A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure · NA · not yet recruiting
- NCT07195708 — Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07015424 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
- Last refreshed: 28 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07015424.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing