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MagDI Diversion Feasibility Study

Primary Purpose

Type 2 Diabetes, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
MAGNET System, DI Bio-fragmentable
Sponsored by
GT Metabolic Solutions, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Type 2 Diabetes

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 30-35 kg/m2 Type 2 diabetes mellitus (T2DM), defined as HbA1c > 6.5%, without previous sleeve gastrectomy, and without plan to perform a concurrent sleeve gastrectomy. 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 Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-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 mo 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. 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/transient ischemic attack (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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 or COVID-19) test prior to the study procedure in accordance with local COVID-19 protocol 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

  • Innova Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MAGNET System, DI Bio-fragmentable

Arm Description

GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System

Outcomes

Primary Outcome Measures

Creation of a patent anastomosis
Confirmed radiologically or fluoroscopically

Secondary Outcome Measures

Full Information

First Posted
January 11, 2023
Last Updated
October 5, 2023
Sponsor
GT Metabolic Solutions, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05692518
Brief Title
MagDI Diversion Feasibility Study
Official Title
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 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
Product Manufactured in and Exported from the U.S.
Yes
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 DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-by-side anastomosis duodeno-ileostomy in obese adults.
Detailed Description
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults. This partial diversion of intestinal contents from duodenum to the ileum is intended to facilitate weight management/loss in obese adults with type 2 diabetes mellitus (T2DM) 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 duodeno-ileostomy (SADI) procedure.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-center, open-label, single-arm, feasibility device study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MAGNET System, DI Bio-fragmentable
Arm Type
Experimental
Arm Description
GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System
Intervention Type
Device
Intervention Name(s)
MAGNET System, DI Bio-fragmentable
Intervention Description
Anastomoses achieved by magnetic compression.
Primary Outcome Measure Information:
Title
Creation of a patent anastomosis
Description
Confirmed radiologically or fluoroscopically
Time Frame
30 Days

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 30-35 kg/m2 Type 2 diabetes mellitus (T2DM), defined as HbA1c > 6.5%, without previous sleeve gastrectomy, and without plan to perform a concurrent sleeve gastrectomy. 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 Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-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 mo 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. 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/transient ischemic attack (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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 or COVID-19) test prior to the study procedure in accordance with local COVID-19 protocol 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
612-222-4200
Email
lgv@gtmetabolic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Schwartz, MS
Email
dan@gtmetabolic.com
Facility Information:
Facility Name
Innova Medical Center
City
Tbilisi
ZIP/Postal Code
N.6
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Abuladze, MD, PhD
Phone
995322232232
Email
davidsur@yahoo.com
First Name & Middle Initial & Last Name & Degree
Magda Abuladze
Phone
995322232232
Email
abuladze30@yahoo.com

12. IPD Sharing Statement

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MagDI Diversion Feasibility Study

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