Clinical trial NCT05322122: Creation of Side-to-Side Compression Anastomosis Using the Magnetic Anastomosis System
Official title: Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnetic Anastomosis System (MAGNET System) to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and With or Without Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: GT Metabolic Solutions, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An operationally seamless, 2-stage, open-label, multicenter study enrolling up to 50 subjects at up to 5 study centers across Canada and Europe:

* 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility and performance measured by anastomosis success
timeFrame: Day 90
Secondary outcomes:
measure: To evaluate the safety of the MAGNET System
timeFrame: Day 30, 90, 180, and 360
measure: Efficacy of weight loss
timeFrame: Day 90, 180, and 360
measure: Efficacy of metabolic improvement
timeFrame: Day 90, 180, and 360
measure: Quality of life improvement
timeFrame: Day 90, 180, and 360
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre
city: Westmount
country: Canada
facility: Westmount Surgical Center
state: Quebec
city: Tbilisi
country: Georgia
facility: Innova Medical Center
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos Complutense University of Madrid
Study officials:
affiliation: Westmount Surgical Center
name: Michel Gagner, MD
role: PRINCIPAL_INVESTIGATOR
References: