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Evaluation of a Novel Endoscopic Suturing Device in a Treat and Resect Model


N/A
18 Years
N/A
Not Enrolling
Both
Colon Malignant Tumor, Colon Benign Tumor

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

Approximately 1 hour post resection of the colon in surgery

Safety Issue:

Yes

Principal Investigator

Jeffrey Marks, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Case Medical Center

Authority:

United States: Institutional Review Board

Study ID:

10-10-31

NCT ID:

NCT01307813

Start Date:

February 2011

Completion Date:

November 2011

Related Keywords:

  • Colon Malignant Tumor
  • Colon Benign Tumor
  • colon distal
  • surgical resection
  • Neoplasms

Name

Location

University Hospitals Case Medical CenterCleveland, Ohio  44106