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Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

NCT06915818 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

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 Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

Conditions

  • Colon Anastomosis

Interventions

DEVICE

Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc

This study will investigate two types of intervention: ileo-colic and colo-colonic anastomosis creation in subjects undergoing colon surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into a portion of either the ileum or the colon that are intended to be anastomosed. An OTOLoc device will be deployed into the ileum/colon wall to provide access for the deployment of a Flexagon SFM into the bowel. The process is repeated at an intended section of colon. 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 · Mohak Hitech Specialty Hospital

  • Vinod Dhakkad, MD · Mohak Hitech Specialty Hospital

  • 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
2026-07-31
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 NCT06915818 on ClinicalTrials.gov