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

NCT ID: NCT05049824

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-26
• Study Completion Date: 2024-10-01

Brief Summary

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

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.

Conditions

Obesity, Morbid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Self Forming Magnetic (SFM) Anastomosis System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GI Windows, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman Turro, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterologist at Teknon Hospital

Locations

Centro Medico Teknon

Barcelona, , Spain

Countries

Spain

Other Identifiers

GIW 19-001

Identifier Type: -

Identifier Source: org_study_id