GI Windows, Inc.
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.
This is a prospective, single-center, single-arm, early feasibility clinical study. Patients who are scheduled for laparoscopic colon surgery requiring an anastomosis will be evaluated for participation in the study. Study Cohorts: * Roll-In (Training) Cohort: A roll-in phase will be included for centers that do not have previous experience with the SFM device. A maximum of 3 roll-in participants will be enrolled. Data from roll-in participants will be summarized separately from the Primary Analysis Cohort. * Primary Analysis Cohort: A minimum of 17 participants undergoing side-to-side Ileo…
Inclusion Criteria: 1. Aged 22 years or older at screening 2. Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection 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 ≥1 months prior to procedure 6. Lives, and intends to remain, within a 150-mile radius of study center for the duration of the study 7. Able to refrain from smoking during study follow-up period Ex…
The SFM plus OTOLoc is used to create an immediate flow compression anastomosis for patients undergoing: Right or Left Hemicolectomy, Sigmoidectomy and Low Anterior resection
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