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Magnet Anastomosis in Patients Undergoing Gastric Surgery

NCT06915337 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-02-13

No results posted yet for this study

Summary

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a gastro-jejunal anastomosis in participants undergoing gastric surgery.

Conditions

  • Gastric Anastomosis (Site)

Interventions

DEVICE

Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc

This study will investigate one type of intervention: gastric-jejunal anastomosis creation in subjects undergoing surgical procedures. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into portions of the stomach and the jejunum that are intended to be anastomosed. An OTOLoc device will be deployed into the gastric wall of the stomach to provide access for the deployment of a Flexagon SFM into the stomach. The process is repeated at an intended section of jejunum. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two lumens until the anastomosis is fully formed.

Sponsors & Collaborators

  • GI Windows, Inc.

    lead INDUSTRY

Principal Investigators

  • Mohit Bhandari, MD · Bhandari Hospital & Research Centre

  • Pablo Marin, MD · Clinica Colonial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-29
Primary Completion
2026-05-31
Completion
2026-06-30
FDA Device
Yes

Countries

  • Chile
  • India

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 NCT06915337 on ClinicalTrials.gov