Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorGI Windows, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Known or suspected allergy to silicone, nickel, titanium or Nitinol
BMI > 55 kg/m2
Uncontrolled diabetes (defined as HbA1c >10%)
Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
Trial design
Treatments tested in this trial
- Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov