Apollo Overstitch, a Treat and Resect Model

The Overstitch (Apollo Endosurgery, Austin, Texas) is an FDA cleared product which attaches
to a standard double channel endoscope. The Overstitch can place sutures under endoscopic
guidance, with the goal of reproducing standard surgical techniques. These would include
hemostasis, tissue approximation, anastomosis formation, fixation of intraluminal devices,
or repair/closure of mucosal or full thickness defects such as perforations or endoscopic
mucosal resection (EMR) sites. Knot tying of the endocsopically placed sutures is provided
by an endoscopic cinching device that passes through the channel of the endoscope.

This feasibility trial will evaluate the ability of the Apollo suturing device (Overstitch)
to endocsopically place sutures into normal mucosa, and then "tie" the sutures with the
cinching device. These devices have been utilized effectively in explant, live porcine, and
human cadaver colon and stomach models. In this treat and resect model, sutures would be
placed in a segment of colon or stomach that is being surgically removed via open or
laparoscopic technique for the treatment of benign or malignant disease. The sutures would
be placed in a segment of normal mucosa remote to the pathology being surgically treated.
In addition, the sutures will be placed under direct observation via laparoscopic or open
visualization. After resection of the segment of colon, it will be evaluated grossly for
level of suture placement, evidence of perforation, and quality of suture approximation with
the cinching device.