Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses

NCT07276529 | Recruiting DMC FDA Device

• 1 other identifier: 25-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses in participants undergoing colon surgery. This will be evaluated via a composite safety/effectiveness endpoint of patient success defined as successful creation of the target anastomosis without placement procedure, device or target anastomosis related reoperation through 30 days.

Conditions

Colorectal Cancer; Diverticular Diseases

Outcome Measures

Primary Outcomes (2)

• Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation.

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

  30 days

• Anastomosis success

  is defined as creation of the target anastomosis without need for conversion to open procedure due to inability to create the magnet anastomosis using laparoscopic methods, intraoperative rescue procedure such as stapled or hand-sewed rescue of failed Flexagon SFM placement (i.e. - no magnet anastomosis created in patient) or intraoperative repair of adjacent organ

  30 days

Secondary Outcomes (3)

• No Bleeding at anastomosis

  30 days

• No Leaks at anastomosis

  30 days

• No Obstructions at the anastomosis

  30 days

Study Arms (1)

Flexagon SFM plus OTOLoc for Magnet Colon Anastomosis

EXPERIMENTAL

Patients will receive the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side Colorectal Anastomoses in Patients Undergoing Surgical Procedures via endoscopic or laparoscopic delivery methods

Device: Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses

Interventions

Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses DEVICE

The SFM plus OTOLoc is used to create an immediate flow compression anastomosis for patients undergoing: Right or Left Hemicolectomy, Sigmoidectomy and Low Anterior resection

Flexagon SFM plus OTOLoc for Magnet Colon Anastomosis

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 of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection 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 150-mile 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
• Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit
• Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous failed endoscopy that may suggest difficulty during endoscopic delivery of magnets
• 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.
• Contraindication to general anesthesia

Sponsors & Collaborators

• GI Windows, Inc.: lead

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Diverticular Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis

Study Officials

• Erik Wilson, MD

  Chief Medical Officer

  STUDY CHAIR

Central Study Contacts

Peter J Lukin, BS

CONTACT

9787610183; peter.lukin@giwindows.com

Jessica Musiak, BS

CONTACT

617-501-7697; jessica.musiak@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: November 20, 2025
• First Posted: December 11, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)