Evaluation of a Novel Endoscopic Suturing Device in a Treat and Resect Model
During the colectomy procedure, the intended proximal and distal margins of resection will
be determined, and the protocol will proceed only if it is fully determined that the tissue
will be fully resectable. The overstitch device affixed to a standard double channel
gastroscope will then be advanced transanally into the segment of planned resected colon,
away from the area of disease so as to not interfere with oncologic principles or
post-resection pathologic evaluation. Endoscopic sutures and knot tying cinching elements
will be placed, with a limit of 15 minutes for the total procedure. The entire procedure
will be closely monitored under laparoscopic or open surgical visualization. After suture
placement, the surgical resection will continue as planned. The specimen will then be
examined for depth of suture placement, evidence of perforation, and quality of the suture
approximation with the knot tying element.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
The successful suture approximation with the cinching device is measured by the depth of suture placement,evidence of perforation, and the quality of suture approximation
Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area
Approximately 1 hour post resection of the colon in surgery
Yes
Jeffrey Marks, MD
Principal Investigator
University Hospital Case Medical Center
United States: Institutional Review Board
10-10-31
NCT01307813
February 2011
November 2011
Name | Location |
---|---|
University Hospitals Case Medical Center | Cleveland, Ohio 44106 |