Status:
COMPLETED
Creation of Side-to-Side Compression Anastomosis Using the Magnetic Anastomosis System
Lead Sponsor:
GT Metabolic Solutions, Inc.
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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-huma...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05322122
Start Date
November 18 2021
End Date
April 4 2024
Last Update
June 21 2024
Active Locations (4)
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1
CHU St Pierre
Brussels, Belgium, 1000
2
Westmount Surgical Center
Westmount, Quebec, Canada, H3Z 2P9
3
Innova Medical Center
Tbilisi, Georgia, N.6
4
Hospital Clinico San Carlos Complutense University of Madrid
Madrid, Spain, 28040