Last updated 2 months ago
Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")
35 patients around the world
Available in Chile
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).
GT Metabolic Solutions, Inc.
1Research sites
35Patients around the world
This study is for people with
Obesity
Diabetes
Diabetes mellitus type 2
Requirements for the patient
To 65 Years
All Gender
Medical requirements
- 18-65 years of age, inclusive, at the time of informed consent.BMI 30-50 kg/m2, inclusive with either Type 2 Diabetes Mellitus (T2DM), defined as HbA1c ≥ 6.5%, or Weight regain following previous sleeve gastrectomy (>12 months) and indicated for a gastro-ileal diversion.BMI 35-50 kg/m2, inclusive without previous sleeve gastrectomy, and where Gastro-jejunal diversion is indicated for the first stage, of a 2-stage, one anastomosis gastric bypass (OAGB), or 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.
- 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.
Sites
Clínica MEDS
Recruiting
SponsorGT Metabolic Solutions, Inc.
Study typeInterventional
Conditions
ObesityDiabetes mellitus type 2
Requirements
To 65 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06073457
