Weight Regain study: TORe with OverStitch
Official title Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
ClinicalTrials.gov ID: NCT07015424
What this study is testing
- What it's testing
- This study aims to find out if adding a specific stomach procedure to lifestyle changes leads to more weight loss than lifestyle changes alone.
- Who it's for
- The study is looking for people who have regained weight after having a Roux-en-Y gastric bypass surgery.
- What's involved
- Participants will be assigned to either receive a new stomach procedure (TORe) along with diet, exercise, and coaching, or just the lifestyle coaching. Those in the lifestyle-only group may get the procedure later.
- Time commitment
- The study lasts for 24 months and requires regular follow-up visits.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Current use or use within the three months prior to the treatment visit of over the counter or prescribed weight loss supplements / medications...
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Irvine, California, United States
- Stanford, California, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Irvine, California, United States; Stanford, California, United States; Jacksonville, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.