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

NCT05064722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-15

No results posted yet for this study

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

Interventions

DEVICE

Self Forming Magnets (SFM)

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.

Sponsors & Collaborators

  • GI Windows, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Cottam, MD · Bariatric Medicine Institute, Salt Lake City, UT

  • Walter Medlin, MD · Bariatric Medicine Institute, Salt Lake City, UT

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2024-04-15
Completion
2024-10-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064722 on ClinicalTrials.gov