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

NCT05322122 | Completed DMC

• 1 other identifier: GTM-001
• Study Type: interventional
• Target: 49
• Locations: 4 countries
• Sites: 4

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Feasibility and performance measured by anastomosis success

  The primary feasibility/performance endpoint is the feasibility/performance of side-to-side anastomosis duodeno-ileostomy defined as: * Placement of the MAGNET System (≥ 90% alignment of magnets); and * Passage of magnets without surgical re-intervention; and * Creation of a patent anastomosis, confirmed radiologically. The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated subjects.

  Day 90

Secondary Outcomes (4)

• To evaluate the safety of the MAGNET System

  Day 30, 90, 180, and 360

• Efficacy of weight loss

  Day 90, 180, and 360

• Efficacy of metabolic improvement

  Day 90, 180, and 360

• Quality of life improvement

  Day 90, 180, and 360

Study Arms (1)

Treatment

EXPERIMENTAL

Side-to-side anastomosis duodeno-ileostomy diversion

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

Interventions

Side-to-side anastomosis duodeno-ileostomy diversion procedure DEVICE

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnetic Anastomosis System (The MAGNET System) to Achieve Duodeno-Ileostomy Diversion.

Also known as: The MAGNET System

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GT Metabolic Solutions, Inc.: lead

Study Sites (4)

CHU St Pierre

Brussels, 1000, Belgium

Location

Westmount Surgical Center

Westmount, Quebec, H3Z 2P9, Canada

Location

Innova Medical Center

Tbilisi, N.6, Georgia

Location

Hospital Clinico San Carlos Complutense University of Madrid

Madrid, 28040, Spain

Location

Related Publications (3)

• Dziakova J, Torres A, Odovic M, Esteban JM, Vazquez-Romero M, Castillo A, Sanchez-Pernaute A, Gagner M. Spanish Experience with Latero-Lateral Duodeno-Ileostomy + Sleeve Gastrectomy with Magnet Anastomosis System. Obes Surg. 2024 Sep;34(9):3569-3575. doi: 10.1007/s11695-024-07432-w. Epub 2024 Aug 2.

  PMID: 39093385 DERIVED

• Gagner M, Almutlaq L, Gnanhoue G, Buchwald JN. Magnetic single-anastomosis side-to-side duodeno-ileostomy for revision of sleeve gastrectomy in adults with severe obesity: 1-year outcomes. World J Surg. 2024 Oct;48(10):2337-2348. doi: 10.1002/wjs.12304. Epub 2024 Aug 1.

  PMID: 39090770 DERIVED

• Gagner M, Abuladze D, Koiava L, Buchwald JN, Van Sante N, Krinke T. First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System. Obes Surg. 2023 Aug;33(8):2282-2292. doi: 10.1007/s11695-023-06708-x. Epub 2023 Jul 2.

  PMID: 37393568 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel Gagner, MD

  Westmount Surgical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: April 11, 2022
• Study Start: November 18, 2021
• Primary Completion: June 22, 2023
• Study Completion: April 4, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); BE (1); CA (1); GE (1)