Stanford, CANCT07015424Now EnrollingIRB Ready

Weight Regain Clinical Trial in Stanford, CA

Access cutting-edge weight regain treatment through this clinical trial at a research site in Stanford. Study-provided care at no cost to qualified participants.

Sponsored by Boston Scientific Corporation

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Expert Care in Stanford

Access weight regain specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related weight regain treatment provided free

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Check if you qualify for this weight regain clinical trial in Stanford, CA

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Why Participate?

  • No-Cost Study Care

  • Local to Stanford

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Stanford site if eligible
  4. 4Begin participation

About This Weight Regain Study in Stanford

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.

Sponsor: Boston Scientific Corporation

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Stanford?

Yes, this clinical trial (NCT07015424) has an active research site in Stanford, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Weight Regain Treatment Options in Stanford, CA

If you're searching for weight regain treatment options in Stanford, CA, this clinical trial (NCT07015424) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Stanford research site is actively enrolling participants for this clinical trial. You'll receive care from experienced weight regain specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all weight regain clinical trials near you to find additional studies recruiting in your area.

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