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De klinische studie NCT05692518 voor Type 2 diabetes, Obesitas is actief, niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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MagDI Diversion Feasibility Study

Actief, niet rekruterend
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De klinische studie NCT05692518 is een interventioneel studie bij Type 2 diabetes, Obesitas met de status actief, niet rekruterend. Het doel is om 9 deelnemers te includeren vanaf 19 december 2022. De studie wordt geleid door GT Metabolic Solutions, Inc. en de voltooiing is gepland op 1 augustus 2025. Laatste update op ClinicalTrials.gov: 23 juli 2025.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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.
Officiële titel

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

Aandoeningen
Type 2 diabetesObesitas
Andere studie-ID's
  • GTM-005
NCT-ID
NCT05692518
Startdatum (Werkelijk)
2022-12-19
Laatste update geplaatst
2025-07-23
Verwachte einddatum
2025-08
Inschrijving (Geschat)
9
Studietype
Interventioneel
FASE
N.v.t.
Status
Actief, niet rekruterend
Primaire doel
Haalbaarheids van medische hulpmiddelen
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelMAGNET System, DI Bio-fragmentable
GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System
MAGNET System, DI Bio-fragmentable
Anastomoses achieved by magnetic compression.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Creation of a patent anastomosis
Confirmed radiologically or fluoroscopically
30 Days
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  1. 18-65 years of age, inclusive, at the time of informed consent
  2. BMI 30-35 kg/m2
  3. Type 2 diabetes mellitus (T2DM), defined as HbA1c > 6.5%, without previous sleeve gastrectomy, and without plan to perform a concurrent sleeve gastrectomy.
  4. Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study
  5. If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
  6. Willing and able to comply with protocol requirements

  1. Type 1 diabetes
  2. Use of injectable insulin
  3. Uncontrolled T2DM
  4. Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure
  5. Uncontrolled hypertension, dyslipidemia or sleep apnea
  6. Prior intestinal, colonic or duodenal surgery, other than bariatric
  7. Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy.
  8. Refractory gastro-esophageal reflux disease (GERD)
  9. Barrett's disease
  10. Helicobacter pylori positive and/or active ulcer disease
  11. Large hiatal hernia
  12. Inflammatory bowel or colonic diverticulitis disease
  13. Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
  14. Implantable pacemaker or defibrillator
  15. Psychiatric disorder, except well-controlled depression with medication for > 6 mo
  16. History of substance abuse
  17. Woman who is either pregnant or breast feeding
  18. Woman of childbearing potential who does not agree to use an effective method of contraception.
  19. 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.
  20. Any anomaly preventing/contraindicating laparoscopic access and general laparoscopic procedures
  21. Had surgical or interventional procedure within 30 days prior to procedure
  22. Any scheduled surgical or interventional procedure planned within 30 days post-procedure
  23. Any stroke/transient ischemic attack (TIA) within 6 months prior to consent
  24. Requires chronic anticoagulation therapy (except aspirin)
  25. Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure
  26. Unable to comply with the follow-up schedule and assessments
  27. Recent tobacco or nicotine product cessation within < 3 months prior to informed consent
  28. Known allergies to the device components or contrast media
  29. Limited life expectancy due to terminal disease
  30. Currently participating in another clinical research study with an investigational drug or medical device
  31. 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
  32. 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)
GT Metabolic Solutions, Inc. logoGT Metabolic Solutions, Inc.
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen
Innova Medical Center, Tbilisi, N.6, Georgia