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 and hereafter referred to as the DI Magnet System) for creation of a side-to-side jejuno-ileal anastomosis in adults with obesity and type 2 diabetes mellitus (T2DM).
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 and hereafter referred to as the DI Magnet System) for creation of a side-to-side jejuno-ileal anastomosis in adults with obesity and type 2 diabetes mellitus (T2DM). This partial diversion of intestinal contents from jejunum to the ileum is intended to facilitate weight management/loss and improve metabolic outcomes. Side-by side anastomoses are currently created by sutures, staples, and anastomotic compression devices. This study explores a partial jejuno-ileal diversion procedure creating a side-to-side anastomosis with magnetic compression anastomosis.
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 single-center study enrolling up to 10 subjects in the Czech Republic
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 30-40 kg/m2 3. 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. Plan to perform a sleeve gastrectomy with the jejuno-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 postprocedure 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. Any condition that, in the investigator's opinion, may preclude completion of followup 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 |
|---|---|---|
| Feasibility and performance of the side-to-side anastomosis for jejuno-ileal diversion using the DI Magnet System. | From date of study index procedure through 90 days | The jejuno-ileal diversion will be considered feasible if it results in successful: * Placement of the Magnet System (≥ 90% alignment of magnets); and * Creation of a patent anastomosis confirmed radiologically, and * Passage of magnets without any surgical re-interventions. The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated participants. |
| Safety of the DI Magnet System | Procedure, Day 90, Day 180, Day 360 | Freedom from serious adverse events related to the study device or study device procedure requiring additional emergency surgery or re-intervention, including: * All-cause mortality * Intestinal perforation and/or peritonitis * Intestinal obstruction * Life-threatening bleeding * Incidence of device malfunctions |
Countries
Czechia
Outcome results
None listed