The objectives of this study are to determine the safety and effectiveness of the SFM Anastomosis Device when used to create a small bowel anastomosis for patients undergoing ileostomy reversal as compared with a propensity-matched historic control group of patients who underwent ileostomy reversal using a conventional closure technique (sutures or stapler).
This is a multicenter, single-arm study in which clinical outcomes prospectively evaluated for a minimum of 100 subjects undergoing ileostomy reversal using the SFM Anastomosis Device will be 1:1 propensity score matched through nearest neighbor matching to a historical control cohort of patients who underwent ileostomy reversal using conventional closure techniques. In order to have a sufficient pool of retrospective patients for matching, retrospective data will be collected for a minimum of 300 patients. The historical control cohort will be accrued from the same pool of institutions participating in the prospective study. Eligibility criteria will be standardized between the prospective investigational treatment arm and the historical control. Within this analysis, propensity score (PS) matching will be used to reduce bias due to potential differences in key covariates between the prospective and retrospective cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
The magnets will be manually deployed into the small intestine during open surgery following creation of a mini or full laparotomy as clinically indicated. Once the desired segment of small bowel is resected, the magnet is inserted through the open ends of each bowel section. Once proper magnet position is confirmed and the bowel ends are approximated, the magnets couple to form the anastomosis.
Advent Health
Orlando, Florida, United States
Colon and Rectal Clinical of Orlando
Orlando, Florida, United States
Beth Israel Deaconess Medical Center
Achieving anastomosis success
The primary effectiveness hypothesis is that anastomosis success rate for the SFM device will be non-inferior to the anastomosis success rate observed for the propensity-matched historical control group
Time frame: 30 days
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Boston, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Spectrum Health / Ferguson Clinic
Grand Rapids, Michigan, United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
The Mount Sinai Medical Center
New York, New York, United States
St Francis Hospital
Roslyn, New York, United States
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Winston-Salem, North Carolina, United States
...and 4 more locations