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

NCT05049824 | Completed

• 1 other identifier: GIW 19-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  1\. Weight loss measured as a percent of total body weight (TBW)

  12 Months

Secondary Outcomes (8)

• Percent responders

  12 Months

• Excess weight loss

  12 Months

• Change in serum lipids

  12 Months

• Change in blood pressure

  12 Months

• Change in fasting glucose

  12 Months

Study Arms (1)

SFM Treatment Arm

EXPERIMENTAL

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

Interventions

Self Forming Magnetic (SFM) Anastomosis System 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

SFM Treatment Arm

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• GI Windows, Inc.: lead

Study Sites (1)

Centro Medico Teknon

Barcelona, Spain

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roman Turro, MD

  Gastroenterologist at Teknon Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: October 26, 2021
• Primary Completion: July 25, 2023
• Study Completion: October 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)