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-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses with the Flexagon 25mm SFM system plus OTOLoc. Patients providing informed consent and meeting all eligibility criteria will be scheduled for surgery. All operations will be conducted by experienced general surgeons and gastroenterologists trained in the use of the Flexagon SFM System plus OTOLoc and procedures will be performed under general anesthesia. Clinical follow-up for all participants will occur at Discharge, Day 7, 30, and 60.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
Orlando Health
Orlando, Florida, United States
RECRUITINGSuccessful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation.
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM plus OTOLoc without placement procedure, device or target anastomosis-related reoperation through 30 days.
Time frame: 30 days
Anastomosis success
is defined as creation of the target anastomosis without need for conversion to open procedure due to inability to create the magnet anastomosis using laparoscopic methods, intraoperative rescue procedure such as stapled or hand-sewed rescue of failed Flexagon SFM placement (i.e. - no magnet anastomosis created in patient) or intraoperative repair of adjacent organ
Time frame: 30 days
No Bleeding at anastomosis
Bleeding Events through 30 days, defined as a target anastomosis related bleeding at the Flexagon SFM placement site requiring transfusion or re-operation.
Time frame: 30 days
No Leaks at anastomosis
Flexagon SFM anastomosis Leak Events through 30 days, as defined by postoperative upper GI or CT evaluation with findings consistent with anastomosis leak, or re-operative findings consistent with anastomosis leak at the Flexagon SFM placement site
Time frame: 30 days
No Obstructions at the anastomosis
Obstruction Events through 30 days as defined by the need for reintervention (e.g., endoscopic opening) or re-operation resulting from Flexagon SFM placement
Time frame: 30 days
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