Megagon Magnet Anastomosis Plus OTOLoc for Creating Colo-colonic and Colorectal Anastomoses

NCT07856342 | Not Yet Recruiting

• 1 other identifier: GIW 26-002
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this trial is to investigate the safety and effectiveness of the Megagon 28.5mm SFM system plus OTOLoc when used to create a colo-colonic and colorectal anastomosis 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

Colo-rectal Anastomosis

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

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

  30 Days

Study Arms (1)

Patients who are scheduled for laparoscopic or hybrid colon surgery requiring an anastomosis will be

EXPERIMENTAL

Anastomosis

Device: Megagon Self-Forming Magnet

Interventions

Megagon Self-Forming Magnet DEVICE

Megagon Self-Forming Magnet

Patients who are scheduled for laparoscopic or hybrid colon surgery requiring an anastomosis will be

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 Colo-colonic or colo-rectal (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 ≥ 1 month 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 for magnet passage
• Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon
• 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 Venous 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.
• A minimum cessation window of four (4) weeks prior to surgery for all biologic agents
• Restarted no earlier than four (4) weeks postoperatively
• 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

Sponsors & Collaborators

• GI Windows, Inc.: lead

Study Officials

• Mohit Bhandari, MD

  Mohak Hitech Specialty Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lukin COO

CONTACT

9787610183; 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: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): November 16, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09