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

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.

Trial Details

NCT ID
NCT07276529
Phase
NA
Sponsor
GI Windows, Inc.
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses
Locations (sample)
  • Orlando, Florida, United States|28.53834,-81.37924
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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