Apollo Overstitch, a Treat and Resect Model

This study has been completed.
Sponsor:
Collaborator:
Apollo Endosurgery, Inc.
Information provided by (Responsible Party):
Jeffrey Marks, MD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01307813
First received: March 2, 2011
Last updated: August 17, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Colon Malignant Tumor
Colon Benign Tumor
Device: Overstitch Endoscopic Suturing System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of a Novel Endoscopic Suturing Device in a Treat and Resect Model

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • 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 [ Time Frame: Approximately 1 hour post resection of the colon in surgery ] [ Designated as safety issue: Yes ]
    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


Enrollment: 4
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Feasibility
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307813

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Apollo Endosurgery, Inc.
Investigators
Principal Investigator: Jeffrey Marks, MD University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Jeffrey Marks, MD, General Surgeon, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01307813     History of Changes
Other Study ID Numbers: 10-10-31
Study First Received: March 2, 2011
Last Updated: August 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
colon distal
surgical resection

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014