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

Study acronym: REIGNITE
StatusRecruiting
PhaseNot applicable
Started2026-04-14
View on ClinicalTrials.gov ↗

Amendment history

2026-09-17
Trial sites expanded: 9 → 12 locations
2026-08-17
Study Status, Contacts/Locations v17
Study sitesdetails revised at 1 of 9 sites
2026-07-07
Study Status, Contacts/Locations v16
Study sitescontacts updated at 1 of 9 sites
2026-06-11
Study Status v15
Re-verified, no change to tracked fields
2026-05-28
Study Status, Contacts/Locations v14
Study sitesdetails revised at 1 of 9 sites
Show 13 earlier versions
2026-05-20
Study Status v13
Re-verified, no change to tracked fields
2026-04-24
Study Status, Contacts/Locations v12
Start dateestimated 2026-04→confirmed 2026-04-14
Study sitesdetails revised at 1 of 9 sites
2026-04-03
Study Status, Contacts/Locations v11
Start date2026-03→2026-04
Study sitesdetails revised at 1 of 9 sites
2026-03-23
Study Status, Contacts/Locations v10
Start date2026-02→2026-03
Study sites10→9
2026-02-19
Study Status v9
Re-verified, no change to tracked fields
2026-02-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Start date2026-01→2026-02
Study sitesdetails revised at 10 of 10 sites
2026-01-21
2 amendments v6-v7
2 re-verifications since 2025-12-16, no change to tracked fields
2025-11-19
Study Status v5
Primary completion date2027-02→2026-11
Completion date2029-09→2028-11
Start date2025-11→2026-01
2025-10-16
Study Status v4
Re-verified, no change to tracked fields
2025-09-26
Study Status, Eligibility, Contacts/Locations v3
Study sites1→10
Eligibility criteria+2 characters
[...] 20 mm, confirmed either during a Screening EGD completed ≤ 3060 days from study procedure or EGD performed immediately prio [...] uction at the time of treatment (pouch that is shorter than 126 cm in length). Agrees not to take additional over the count [...] g System. Exclusion Criteria: Current use or use within the onethree monthmonths prior to the baseline visit of over the counter or prescrib [...]
2025-08-21
2 amendments v1-v2
2 re-verifications since 2025-07-28, no change to tracked fields
2025-06-03
Original filing
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.
Trial Details
NCT Number NCT07015424
Lead Sponsor Boston Scientific Corporation
Conditions Weight Regain, Weight Loss
Enrollment 108 participants
Start Date 2026-04-14
Primary Completion 2026-11 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-16