Creation of Side-to-Side Compression Anastomosis Using the Magnetic Anastomosis System

GT Metabolic Solutions

Status

Completed

Conditions

Obesity

Treatments

Device: Side-to-side anastomosis duodeno-ileostomy diversion procedure

Study type

Interventional

Funder types

Industry

Identifiers

NCT05322122

GTM-001

Details and patient eligibility

About

This is an operationally seamless, open-label, multicenter study enrolling up to 50 subjects with obesity and with or without type 2 diabetes at up to 5 study centers across Canada and Europe who will undergo sleeve gastrectomy (revision or de novo) with side-to-side anastomosis duodeno-ileostomy using the MAGNET System and will be followed for 12 months.

Full description

The MAGNET study is an operationally seamless, 2-stage, open-label, multicenter study enrolling up to 50 subjects at up to 5 study centers across Canada and Europe as follows:

Stage 1 first-in-human (FIH) and proof-of-concept with 5 subjects; and
Stage 2 feasibility with 45 subjects.

There will be a pause after completing enrollment in Stage 1 to allow completion of Day 30 and evaluation of safety by the independent Data Safety Monitoring Committee (DSMB). The DSMB will confirm whether the study can advance to Stage 2. All subjects in Stage 1 and 2 will be followed for 12 months.

Study Procedure: Side-to-side anastomosis duodeno-ileostomy diversion procedure using the MAGNET System

Study Population: Adults (18 to 65 years of age, inclusive) with obesity (BMI 30-50) who meet one of the following criteria: (1) have type 2 diabetes mellitus (T2DM) or experienced weight regain following previous sleeve gastrectomy; (2) have T2DM without previous sleeve gastrectomy; or (3) are candidates for a laparoscopic single anastomosis duodenal-ileal bypass with sleeve (SADI-S) procedure and have BMI ≥ 40.

Follow-up: Each subject will return for 6 follow-up visits at Day 14, 30, 60, 90, 180, 270 and 360 (end of study).

Enrollment

49 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18-65 years of age, inclusive, at the time of informed consent
BMI 30-50, inclusive with either:
- Previous-sleeve gastrectomy (> 12 months) with either T2DM (defined as HbA1c > 6.5%) or weight regain; or
- T2DM without previous gastrectomy; or
- Undergoing laparoscopic single anastomosis duodenal-ileal bypass with sleeve (SADI-S) where duodeno-ileostomy is performed side to side with the MAGNET System and BMI > 40
Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for 1 year
If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for 1 year
Willing and able to comply with protocol requirements

Exclusion criteria

Type 1 diabetes
Use of injectable insulin
Uncontrolled T2DM
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 disorders, except well-controlled depression with medication for >6mo, or 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. This includes any conditions for which endoscopic or laparoscopic surgery would be contraindicated, and 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 need for MR imaging within the first 2 months after the procedure
Any anomaly preventing/contraindicating laparoscopic access and general laparoscopic procedures
Had surgical or interventional procedure within 30 days prior to procedure
Any scheduled surgical or interventional procedure planned within 30 days post-procedure
Any stroke/TIA within 6 months prior to 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 within < 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
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)