Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery (FOCUS)

GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures

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.

Study Overview

• Status: Recruiting
• Conditions: Colon Anastomosis
• Intervention / Treatment: Device: Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc

Detailed Description

This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Lukin; Phone Number: +1 7814717901; Email: peter.lukin@giwindows.com

Study Locations

• Chile
  • Huechuraba, Región Metropolitana
    • Santiago, Huechuraba, Región Metropolitana, Chile, 8580000
      • Not yet recruiting
      • Clínica Colonial Hospital
      • Contact: Pablo Marin, MD; Phone Number: +56982947291; Email: doctorpablomarin@gmail.com
      • Contact: Francesca Gorziglia, MD; Phone Number: +56985007583; Email: francesca.gorziglia@gmail.com
• India
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 454555
      • Recruiting
      • Mohak Hitech Specialty Hospital
      • Principal Investigator: Mohit Bhandari, MD
      • Contact: Mohit Bhandari, MD; Phone Number: (+91) 7314231753
      • Principal Investigator: Vinod Dhakkad, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Known or suspected allergy to silicone, nickel, titanium or Nitinol
2. BMI > 55 kg/m2
3. Uncontrolled diabetes (defined as HbA1c >10%)
4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
5. Diagnosed with obstructed or perforated colon cancer
6. 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
7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon
8. History of recurrent small bowel obstructions.
9. Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL
10. Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2) or ongoing dialysis
11. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
12. 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
13. 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)
14. Decompensated chronic obstructive lung disease
15. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
16. Contraindication to general anesthesia
17. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
18. Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
19. Contraindication to general anesthesia
20. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GI Windows, Inc.
• Investigators: Principal Investigator: Mohit Bhandari, MD, Mohak Hitech Specialty Hospital; Principal Investigator: Vinod Dhakkad, MD, Mohak Hitech Specialty Hospital; Principal Investigator: Pablo Marin, MD, Clínica Colonial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GIW 25-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes