Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")

Sponsor

GT Metabolic Solutions, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06073457

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Obesity Type 2 Diabetes	Device: MagGJ System	N/A

Detailed Description

The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults. This partial diversion of intestinal contents from the stomach to the ileum or jejunum is intended to facilitate weight management/loss in obese adults and improve metabolic outcomes in obese adults with type 2 diabetes mellitus ("T2DM"). Side-by-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single anastomosis sleeve ileal (SASI) bypass procedure that includes a gastro-ileostomy at the distal antrum of the stomach. Additionally, the one anastomosis gastric bypass (OAGB) or single anastomosis gastric bypass (SAGB) performed in two stages may also be considered a predicate procedure where an anastomosis between the jejunum and anterior lesser curvature of the stomach is performed, followed by a second stage gastric pouch stapling more than 12 months later (non-study procedure).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A 2-stage, open-label, multicenter study enrolling up to 35 subjects at 6 study centers, as follows: Stage 1: First-in-human (FIH) and proof-of-concept with up to 5 subjects; and Stage 2: Feasibility with up to 30 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.A 2-stage, open-label, multicenter study enrolling up to 35 subjects at 6 study centers, as follows:Stage 1: First-in-human (FIH) and proof-of-concept with up to 5 subjects; and Stage 2: Feasibility with up to 30 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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, GJ Biofragmentable to Achieve Gastro-Ileal or Gastro-Jejunal Diversion in Adults With Obesity

Anticipated Study Start Date :

Oct 31, 2023

Anticipated Primary Completion Date :

Oct 30, 2024

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MagGJ System GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System")	Device: MagGJ System Anastomoses achieved by magnetic compression.

Arm

Intervention/Treatment

Experimental: MagGJ System

GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System")

Device: MagGJ System

Anastomoses achieved by magnetic compression.

Outcome Measures

Primary Outcome Measures

Magnet Placement [1 Day]
MagGJ System placement ≥ 90% alignment of magnets
Natural Magnet Passage [30 Days]
Passage of magnets without surgical re-intervention
Anastomosis Patency [Day 30]
Confirmed radiologically or fluoroscopically

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-65 years of age, inclusive, at the time of informed consent
BMI 30-50 kg/m2, inclusive with either (A) Type 2 Diabetes Mellitus (T2DM), defined as HbA1c ≥ 6.5%, or (B) Weight regain following previous sleeve gastrectomy (>12 months) and indicated for a gastro-ileal diversion; OR
BMI 35-50 kg/m2, inclusive without previous sleeve gastrectomy, and where (A) Gastro-jejunal diversion is indicated for the first stage, of a 2-stage, one anastomosis gastric bypass (OAGB), or (B) Single anastomosis gastric bypass (SAGB), with the second stage gastric pouch stapling performed >12 months after the gastro-ileal diversion, and not part of the investigational study
Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study
If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
Willing and able to comply with protocol requirements

Exclusion Criteria:

Type 1 diabetes
Use of injectable insulin
Uncontrolled T2DM
Plan to perform a sleeve gastrectomy and/or hiatal hernia repair and/or cholecystectomy with the investigational study gastro-ileal anastomosis procedure
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 disorder, except well-controlled depression with medication for > 6 months
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, including 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 MR imaging within a two-month window following the study procedure
Any anomaly preventing/contraindicating endoscopic or laparoscopic access and procedures
Underwent a surgery/intervention within the 30 days proceeding the study procedure
Any scheduled surgical or interventional procedure planned within 30 days post-study procedure
Any stroke/TIA within 6 months prior to informed 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; cessation ≤ 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, where indicated by local COVID-19 protocols for procedure/surgical clearance
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

GT Metabolic Solutions, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GT Metabolic Solutions, Inc.

ClinicalTrials.gov Identifier:

NCT06073457

Other Study ID Numbers:

GTM-003

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Oct 10, 2023