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

January 18, 2024 updated by: GT Metabolic Solutions, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnet Placement
Time Frame: 1 Day
MagGJ System placement ≥ 90% alignment of magnets
1 Day
Natural Magnet Passage
Time Frame: 30 Days
Passage of magnets without surgical re-intervention
30 Days
Anastomosis Patency
Time Frame: Day 30
Confirmed radiologically or fluoroscopically
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GT Metabolic Solutions, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTM-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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