Apollo Overstitch, a Treat and Resect Model (Overstitch)

Evaluation of a Novel Endoscopic Suturing Device in 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 endoscopically 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 endoscopically 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.

Study Overview

• Status: Completed
• Conditions: Colon Malignant Tumor; Colon Benign Tumor
• Intervention / Treatment: Device: Overstitch Endoscopic Suturing System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient population in this study will be candidates of either sex, over 18' who have an established indication for a surgical procedure requiring resection of a portion of colon distal to the splenic flexure. This will include both benign and malignant diseases.

Exclusion Criteria:

• Any underlying pathology in the determination of investigator that subject cannot undergo scoping
• Sutures cannot be placed in segment of bowel that will be included in the surgical resection
• Pregnant women will be excluded from participating in this protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endoscopic suturing device; 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.

Device: Overstitch Endoscopic Suturing System; 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. Patients will already require resection of segments of colon for treatment of benign or malignant disease and this will therefore be a treat and resect model; Other Names: Endoscopic suturing and cinching device; for placement of sutures and surgical knots

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Suture Approximation With Cinching Device	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. The quality of cinch element effectiveness was graded on a four-point Likert scale (1 = Poor, 2 = Good, 3 = Very Good, 4 = Excellent).	Approximately 1 hour post resection of the colon in surgery
Successful Suture Approximation With Cinching Device	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. When two tissue bites were taken within an individual stitch, the quality of mucosal approximation was graded on a four-point Likert scale (1 = Poor, 2 = Good, 3 = Very Good, 4 = Excellent).	Approximately 1 hour post resection of the colon in surgery

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Apollo Endosurgery, Inc.
• Investigators: Principal Investigator: Jeffrey Marks, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: March 2, 2011
• First Submitted That Met QC Criteria: March 2, 2011
• First Posted (Estimate): March 3, 2011

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: surgical resection; colon distal
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 10-10-31