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

GI Windows

Status: Enrolling

Conditions: Colon Anastomosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06915818

GIW 25-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc

Experimental group

Description:

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.

Treatment:

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