Using magnets for weight loss surgery in obese adults
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, GJ Biofragmentable to Achieve Gastro-Ileal or Gastro-Jejunal Diversion in Adults With Obesity
This study is testing a new magnet system for weight loss surgery in obese adults to see if it works better than traditional methods for helping with weight management and improving diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | GT Metabolic Solutions, Inc. Industry-sponsored |
| Locations | 4 sites (Westmount, Quebec and 3 other locations) |
| Trial ID | NCT06073457 on ClinicalTrials.gov |
What this trial studies
This clinical research evaluates the feasibility of the GT Metabolic Solutions Magnet System for creating a side-to-side anastomosis in obese adults. The procedure aims to facilitate weight management and improve metabolic outcomes, particularly for those with type 2 diabetes. It compares the magnet system to traditional methods like sutures and staples for intestinal diversion. Participants will be monitored for their ability to comply with study requirements and the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are obese adults aged 18-65 with a BMI of 30-50 and type 2 diabetes or those who have regained weight after previous bariatric surgery.
Not a fit: Patients with a BMI outside the specified range or those who have not previously undergone bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive option for weight loss and improved metabolic health in obese patients.
How similar studies have performed: While similar surgical approaches have been tested, the use of the magnet system for this specific procedure is novel and has not been widely studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-65 years of age, inclusive, at the time of informed consent * BMI 30-50 kg/m2, inclusive with either (A) Type 2 Diabetes Mellitus (T2DM), defined as HbA1c ≥ 6.5%, or (B) Weight regain following previous sleeve gastrectomy (\>12 months) and indicated for a gastro-ileal diversion; OR * BMI 35-50 kg/m2, inclusive without previous sleeve gastrectomy, and where (A) Gastro-jejunal diversion is indicated for the first stage, of a 2-stage, one anastomosis gastric bypass (OAGB), or (B) Single anastomosis gastric bypass (SAGB), with the second stage gastric pouch stapling performed \>12 months after the gastro-ileal diversion, and not part of the investigational study * Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study * If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study * Willing and able to comply with protocol requirements Exclusion Criteria: * Type 1 diabetes * Use of injectable insulin * Uncontrolled T2DM * Plan to perform a sleeve gastrectomy and/or hiatal hernia repair and/or cholecystectomy with the investigational study gastro-ileal anastomosis procedure * Uncontrolled hypertension, dyslipidemia or sleep apnea * Prior intestinal, colonic or duodenal surgery, other than bariatric * Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy. * Refractory gastro-esophageal reflux disease (GERD) * Barrett's disease * Helicobacter pylori positive and/or active ulcer disease * Large hiatal hernia * Inflammatory bowel or colonic diverticulitis disease * Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques. * Implantable pacemaker or defibrillator * Psychiatric disorder, except well-controlled depression with medication for \> 6 months * History of substance abuse * Woman who is either pregnant or breast feeding * Woman of childbearing potential who does not agree to use an effective method of contraception. * Any comorbidity or current status of subject's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the subject medically unfit for the procedure, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the magnets. * Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target magnet deployment site * Expected MR imaging within a two-month window following the study procedure * Any anomaly preventing/contraindicating endoscopic or laparoscopic access and procedures * Underwent a surgery/intervention within the 30 days proceeding the study procedure * Any scheduled surgical or interventional procedure planned within 30 days post-study procedure * Any stroke/TIA within 6 months prior to informed consent * Requires chronic anticoagulation therapy (except aspirin) * Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure * Unable to comply with the follow-up schedule and assessments * Recent tobacco or nicotine product cessation; cessation ≤ 3 months prior to informed consent * Known allergies to the device components or contrast media * Limited life expectancy due to terminal disease * Currently participating in another clinical research study with an investigational drug or medical device * A positive COVID-19 test prior to the study procedure, where indicated by local COVID-19 protocols for procedure/surgical clearance * Any condition that, in the investigator's opinion, may preclude completion of follow-up assessments through Day 360 (e.g., a medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, or poor compliance with treatment regimen)
Where this trial is running
Westmount, Quebec and 3 other locations
- Westmount Surgical Center — Westmount, Quebec, Canada (Recruiting)
- Clinica MEDS La Dehesa SpA — Santiago, Chile (Recruiting)
- Hospital Lusiadas Amadora — Amadora, Portugal (Recruiting)
- Cleveland Clinic Abu Dhabi — Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Study coordinator: Lisa Griffin Vincent, PhD
- Email: clinical@gtmetabolic.com
- Phone: +1 763-200-1416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.