Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04627103
Other study ID # GIW 20-001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 7, 2021
Est. completion date November 30, 2024

Study information

Verified date June 2024
Source GI Windows, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.


Description:

Multi-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 18
Est. completion date November 30, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria: - Age 19-65 years at screening - Body mass index (BMI) =35 and =50 - T2DM diagnosis =6 months but < 10 years, with 1 or more oral diabetes medications, HbA1c = 6.5% but < 10.0% at time of enrollment. - HbA1c must be stable over a 3-month period. - Weight stable over 3-month period - Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled - Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years - If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period - Able to understand and sign informed consent documents. Exclusion Criteria: - Known or suspected allergy to nickel or titanium or nitinol - Type 1 diabetes or poorly controlled type 2 diabetes - Use of injectable insulin - Any documented conditions for which endoscopy would be contraindicated - Contraindication to general anesthesia - History of chronic gastrointestinal disease - Congenial or acquired anomalies of the GI tract - Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon. - Uncontrolled hypertension - Pre-existing severe comorbid cardio-respiratory disease - History of chronic gastrointestinal disease - Specific genetic or hormonal cause of obesity - Recent tobacco/nicotine product cessation (within 3 months prior)

Study Design


Intervention

Device:
Self Forming Magnetic (SFM) Anastomosis System
The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact Type 2 Diabetes. Following the diversion being created, a gastric sleeve will be created according to standard technique.

Locations

Country Name City State
Canada QEII Health Sciences Centre Halifax Nova Scotia
Canada Université Laval Quebec City Quebec

Sponsors (1)

Lead Sponsor Collaborator
GI Windows, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight Loss Weight loss measured as a percent of total body weight (TBW) 12 months
Secondary Percent Responders Percent responders; i.e. percent of subjects losing at least 10% TBW 12 months
Secondary Excess Weight Loss Measures Excess weight loss (EWL) 12 months
Secondary Absolute Weight Loss Measures Absolute weight loss 12 months
Secondary BMI - Weight Loss Measures Change in BMI 12 months
Secondary Fasting Glucose Mean change in fasting glucose 12 months
Secondary Hemoglobin A1c Mean change in Hemoglobin A1c 12 months
Secondary Diabetes Remission and/or Improvements Proportion of subjects experiencing diabetes remission and/or improvements 12 months
Secondary Diabetes Medication Dosage and Frequency Changes Mean change in the dosage and frequency of diabetes medications from baseline 12 months
Secondary Serum Lipids Mean change in serum lipids 12 months
Secondary Blood Pressure Changes Mean percent change in systolic/diastolic blood pressure 12 months
Secondary Liver Changes using Fibroscan Change in Controlled Attenuation Parameter (CAP) Scores from baseline 12 months
Secondary Nutritional Status Nutritional Status: changes in pre-albumin levels 12 months
Secondary Albumin - Nutritional Status Nutritional Status: changes in albumin levels 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2