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Clinical Trials in India / NCT06915818
Recruiting Not applicable

Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

NCT06915818 · tracked via the Priya Life Science India tracker
Sponsor
GI Windows, Inc.
Phase
Not applicable
Started
2025-03-29
Last updated
2026-07-06

Condition(s) studied

Colon Anastomosis

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
Healthy volunteers
No
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 outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Clinica Colonial Hospital Santiago Huechuraba, Región Metropolitana Not Yet Recruiting
Mohak Hitech Specialty Hospital Indore Madhya Pradesh Recruiting

More GI Windows, Inc. trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06915818 on ClinicalTrials.gov ↗ ← All trials in India