Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve or Those With Inadequate Weight Loss After Sleeve

NCT05064722 | Completed DMC FDA Device

• 1 other identifier: GIW 21-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a dual-path duodenal-ileal (D-I) diversion either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure). Additionally, the study is designed to evaluate the potential of the SNAP-S/SNAP-PS procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  Total Body Weight Loss from baseline

  12 months

Secondary Outcomes (5)

• Percent Responders

  12 Months

• %EWL

  12 Months

• Serum lipids

  12 Months

• Systolic/diastolic blood pressure

  12 Months

• Hemoglobin A1c

  12 Months

Study Arms (2)

SNAP-S

EXPERIMENTAL

Creation of a D-I diversion in participants undergoing primary sleeve gastrectomy (SNAP-S cohort)

Device: Self Forming Magnets (SFM)

SNAP-PS

EXPERIMENTAL

Creation of a D-I diversion in participants who have experienced inadequate weight loss following sleeve gastrectomy (SNAP-PS cohort)

Device: Self Forming Magnets (SFM)

Interventions

Self Forming Magnets (SFM) DEVICE

To create the duodenal-ileal diversion, the duodenal magnet will be placed transorally in the proximal duodenum and the distal magnet will be placed in the ileum. Magnets are coupled and a compression induced anastomosis is created.

SNAP-PS; SNAP-S

Eligibility Criteria

• Age: 22 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
• Obesity with Body Mass Index (BMI) ≥ 35 kg/m2 with at least one obesity related comorbidity or ≥ 40 but ≤ 50 kg/m2 with or without comorbidities at time of screening.
• a. For SNAP-PS Cohort, subject should be at least 18 months from the initial sleeve gastrectomy and have failed to achieve at minimum 50% EWL
• If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
• Able to understand and sign informed consent document
• Patient lives, and intends to remain, within a 300-km radius of study center for 24 months
• Willing to refrain from smoking during the study follow-up period
• If subject is female, she must commit to not becoming pregnant for 24 months and agree to use of contraceptives during this period and may not be nursing

You may not qualify if:

• Type 1 Diabetes
• Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) and/or hemoglobin A1c \>10 or use of injectable insulin
• Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
• Contraindication to general anesthesia
• Clinically significant finding during procedural endoscopy such as presence of an unhealed ulcers, bleeding lesions, tumors or ischemic or necrotic tissue at target magnet deployment site
• Congenital or acquired anomalies of the GI tract, including atresias, stenosis, prior obstruction or malrotation
• Presence of a duodenal diverticulum (\>10mm)
• Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy for SNAP-PS cohort), pancreas or right colon
• History of chronic gastrointestinal disease (e.g., cirrhosis, inflammatory bowel disease) that in the opinion of the Investigator may preclude safe and complete study participation
• Uncontrolled severe hypertension (blood pressure \>160/100mmHg)
• Pre-existing severe comorbid cardio-respiratory disease (e.g., congestive heart failure, uncontrolled cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease requiring supplemental oxygen, pulmonary embolism, MI with prior 6 months)
• Liver biochemistries (ALT and AST) ≥ 3 times the upper limit of normal
• Uncorrectable coagulation disorder (platelets \< 100,000, PT \>2 seconds above control or INR \>1.5) at time of procedure, Note: management of anti-platelet medications, when applicable, will follow standard practices of the institution
• Uncorrectable anemia (Hemoglobin \< 11 g/dL in women and \<12.5 g/dL in men)
• Specific genetic or hormonal cause of obesity such as Prader -Willi syndrome

Sponsors & Collaborators

• GI Windows, Inc.: lead

Study Sites (1)

Bariatric Medicine Institute

Salt Lake City, Utah, 84102, United States

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

• Daniel Cottam, MD

  Bariatric Medicine Institute, Salt Lake City, UT

  PRINCIPAL INVESTIGATOR

• Walter Medlin, MD

  Bariatric Medicine Institute, Salt Lake City, UT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: November 8, 2021
• Primary Completion: April 15, 2024
• Study Completion: October 9, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)