Clinical trial NCT06915818: Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery
Official title: GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Anastomosis
Lead sponsor: GI Windows, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 56
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Indore
country: India
facility: Mohak Hitech Specialty Hospital
state: Madhya Pradesh
Study officials:
affiliation: Mohak Hitech Specialty Hospital
name: Mohit Bhandari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mohak Hitech Specialty Hospital
name: Vinod Dhakkad, MD
role: PRINCIPAL_INVESTIGATOR
References: