Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy (SNAP-PS)

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

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

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: Device: Self Forming Magnetic (SFM) Anastomosis System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Centro Médico Teknon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SFM Treatment Arm; The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss	1. Weight loss measured as a percent of total body weight (TBW)	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent responders	Percent of subjects losing at least 10% and 20% of baseline weight from baseline	12 Months
Excess weight loss	Mean change in Excess weight loss from baseline	12 Months
Change in serum lipids	Mean change in serum lipids from baseline	12 Months
Change in blood pressure	Mean change in blood pressure from baseline	12 Months
Change in fasting glucose	Mean change in fasting glucose in subjects with T2DM at baseline	12 Months
Change in HbA1c	Mean change in HbA1c in subjects with T2DM at baseline	12 Months
Change in BMI	Mean change in BMI from baseline	12 Months
Change in Absolute Weight Loss	Mean change in Absolute Weight Loss from baseline	12 Months

Collaborators and Investigators

• Sponsor: GI Windows, Inc.
• Investigators: Principal Investigator: Roman Turro, MD, Gastroenterologist at Teknon Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: GIW 19-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No