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

Primary Purpose

Obesity, Type 2 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MagGJ System
Sponsored by
GT Metabolic Solutions, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MagGJ System

    Arm Description

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 17, 2023
    Last Updated
    October 5, 2023
    Sponsor
    GT Metabolic Solutions, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06073457
    Brief Title
    Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 31, 2023 (Anticipated)
    Primary Completion Date
    October 30, 2024 (Anticipated)
    Study Completion Date
    April 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GT Metabolic Solutions, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Type 2 Diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MagGJ System
    Arm Type
    Experimental
    Arm Description
    GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System")
    Intervention Type
    Device
    Intervention Name(s)
    MagGJ System
    Intervention Description
    Anastomoses achieved by magnetic compression.
    Primary Outcome Measure Information:
    Title
    Magnet Placement
    Description
    MagGJ System placement ≥ 90% alignment of magnets
    Time Frame
    1 Day
    Title
    Natural Magnet Passage
    Description
    Passage of magnets without surgical re-intervention
    Time Frame
    30 Days
    Title
    Anastomosis Patency
    Description
    Confirmed radiologically or fluoroscopically
    Time Frame
    Day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lisa Griffin Vincent, PhD
    Phone
    +1 763-200-1416
    Email
    clinical@gtmetabolic.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Josh Schumacher
    Phone
    +1 763-200-1416
    Email
    clinical@gtmetabolic.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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