Obesity, Type 2 Diabetes
Conditions
Brief summary
The purpose of this clinical research study is to evaluate the feasibility / performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults.
Detailed description
The purpose of this clinical research study is to evaluate the feasibility/performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults. This partial diversion of intestinal contents from duodenum to the ileum is intended to facilitate weight management/loss in obese adults with type 2 diabetes mellitus (T2DM) and improve metabolic outcomes in obese adults with type 2 diabetes mellitus (T2DM). Side-by side- anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single-anastomosis duodeno- ileostomy (SADI) procedure.
Interventions
Anastomoses achieved by magnetic compression.
Sponsors
GT Metabolic Solutions, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label, multicenter study enrolling up to 25 subjects at up to 3 study centers in Mexico
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18-65 years of age, inclusive, at the time of informed consent 2. BMI 30-34.9 kg/m2 3. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c 6.5%), without previous sleeve gastrectomy, and without plan to perform a concurrent sleeve gastrectomy. 4. Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study 5. If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study 6. Willing and able to comply with protocol requirements
Exclusion criteria
1. Type 1 diabetes 2. Use of injectable insulin 3. Uncontrolled T2DM 4. Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure 5. Uncontrolled hypertension, dyslipidemia or sleep apnea 6. Prior intestinal, colonic or duodenal surgery, other than bariatric 7. Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy. 8. Refractory gastro-esophageal reflux disease (GERD) 9. Barrett's disease 10. Helicobacter pylori positive and/or active ulcer disease 11. Large hiatal hernia 12. Inflammatory bowel or colonic diverticulitis disease 13. Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques. 14. Implantable pacemaker or defibrillator 15. Psychiatric disorder, except well-controlled depression with medication for \>6 months 16. History of substance abuse 17. Woman who is either pregnant or breast feeding 18. Woman of childbearing potential who does not agree to use an effective method of contraception. 19. 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. 20. Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target magnet deployment site 21. Expected need for MR imaging within the first 2 months after the procedure 22. Any anomaly preventing/contraindicating endoscopic or laparoscopic access and procedures 23. Had surgical or interventional procedure within 30 days prior to procedure 24. Any scheduled surgical or interventional procedure planned within 30 days post- procedure 25. Any stroke/TIA within 6 months prior to consent 26. Requires chronic anticoagulation therapy (except aspirin) 27. Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure 28. Unable to comply with the follow-up schedule and assessments 29. Recent tobacco or nicotine product cessation within \< 3 months prior to informed consent 30. Known allergies to the device components or contrast media 31. Limited life expectancy due to terminal disease 32. Currently participating in another clinical research study with an investigational drug or medical device 33. A positive COVID-19 test prior to the study procedure in accordance with local COVID-19 protocol 34. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnet Placement | 1 Day (during study index procedure) | MagGJ System placement ≥ 90% alignment of magnets |
| Natural Magnet Passage | Index Procedure through 90 days | Passage of magnets without surgical re-intervention |
| Anastomosis Patency | Index Procedure through 90 days | Confirmed radiologically |
Countries
Mexico
Outcome results
None listed