Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

NCT06915818 | Recruiting FDA Device

• 1 other identifier: GIW 25-003
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Successful Anastomosis Creation without the Need for Reoperation

  The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days.

  30 Days

Study Arms (1)

Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc

EXPERIMENTAL

This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing ileo-colic and colo-colonic anastomosis using the Flexagon SFM Device with OTOLoc.

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

Interventions

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

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.

Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 22 years or older at screening
• Candidate for surgery requiring Right Hemicolectomy or Sigmoid / Low Anterior resection (with anastomosis above the peritoneal reflection) with cardiac/medical clearance for surgery
• Able to understand and sign informed consent document
• American Society of Anesthesiologists (ASA) score \< IV at time of procedure
• All cancer patients must have completed chemotherapy ≥2 months prior to procedure
• Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study
• Able to refrain from smoking during study follow-up period

You may not qualify if:

• Known or suspected allergy to silicone, nickel, titanium or Nitinol
• BMI \> 55 kg/m2
• Uncontrolled diabetes (defined as HbA1c \>10%)
• Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
• Diagnosed with obstructed or perforated colon cancer
• Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy that may suggest difficulty during endoscopic delivery of magnets
• Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon
• History of recurrent small bowel obstructions.
• Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL
• Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis
• Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
• Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
• Congestive heart failure with ejection fraction \<35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes)
• Decompensated chronic obstructive lung disease
• Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.

Sponsors & Collaborators

• GI Windows, Inc.: lead

Study Sites (2)

Clinica Colonial Hospital

Santiago, Huechuraba, Región Metropolitana, 8580000, Chile

NOT YET RECRUITING

Mohak Hitech Specialty Hospital

Indore, Madhya Pradesh, 454555, India

RECRUITING

Study Officials

• Mohit Bhandari, MD

  Mohak Hitech Specialty Hospital

  PRINCIPAL INVESTIGATOR

• Vinod Dhakkad, MD

  Mohak Hitech Specialty Hospital

  PRINCIPAL INVESTIGATOR

• Pablo Marin, MD

  Clinica Colonial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lukin

CONTACT

+1 7814717901; peter.lukin@giwindows.com

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: April 2, 2025
• First Posted: April 8, 2025
• Study Start: March 29, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1); IN (1)