Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy

Obesity, Morbid Clinical Trial

— SNAP-PS  

Official title:

Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects With Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05049824
• Other study ID #: GIW 19-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 26, 2021
• Est. completion date: June 25, 2024

Study information

• Verified date: September 2023
• Source: GI Windows, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Single-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 for Subjects with Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: June 25, 2024
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 22-65 years at screening

• Body mass index (BMI) =35 and =50

• Patient is =12 months but = 60 months post sleeve gastrectomy who have inadequate weight loss or weight regain.

• Weight stable over 3-month period

• Negative H. pylori breath test

• 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

• Contraindication to general anesthesia

• Previous technical difficulty or failed endoscopy or contraindication to endoscopy of upper GI series

• Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.

• Clinically significant findings during screening endoscopy at target region for compression anastomosis

• Uncontrolled hypertension

• Pre-existing severe comorbid cardio-respiratory disease

• History of type 1 diabetes or poorly controlled type 2 diabetes

• Abnormal liver biochemistry

• History of chronic gastrointestinal disease

• Specific genetic or hormonal cause of obesity

• Recent tobacco/nicotine product cessation (within 3 months prior)

Related Conditions & MeSH terms

• Obesity, Morbid

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 metabolic disease indicators

Locations

Country	Name	City	State
Spain	Centro Medico Teknon	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
GI Windows, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	1. Weight loss measured as a percent of total body weight (TBW)	12 Months
Secondary	Percent responders	Percent of subjects losing at least 10% and 20% of baseline weight from baseline	12 Months
Secondary	Excess weight loss	Mean change in Excess weight loss from baseline	12 Months
Secondary	Change in serum lipids	Mean change in serum lipids from baseline	12 Months
Secondary	Change in blood pressure	Mean change in blood pressure from baseline	12 Months
Secondary	Change in fasting glucose	Mean change in fasting glucose in subjects with T2DM at baseline	12 Months
Secondary	Change in HbA1c	Mean change in HbA1c in subjects with T2DM at baseline	12 Months
Secondary	Change in BMI	Mean change in BMI from baseline	12 Months
Secondary	Change in Absolute Weight Loss	Mean change in Absolute Weight Loss from baseline	12 Months