Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy - Full Text View

Sponsored by:	Ethicon Endo-Surgery
Information provided by:	Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:	NCT00553436

Purpose

The purpose of this study is to show that the surgical site in the bowel wall can be sewn closed in the colon or intestine, with a new sewing device after removal of a benign polyp according to standard of care.

Condition	Intervention
Polyps	Device: Tissue Apposition following EMR of colonic polyp

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy

Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:

Deployment of tissue anchors and associated knotting element for tissue closure post-EMR tissue apposition. [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
Durability of tissue apposition at three months post-EMR tissue apposition [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Closure of defect following polypectomy

Detailed Description:

Polypectomy is the medical term for removing polyps. Polyps are abnormal like growths that protrude into the lining of the bowel. Because apolyp cannot always be removed by a snare, the usual and simplest method, (for example, it may be too flat), a doctor (colorectal surgeon) may perform a polypectomy using a technique called Endoscopic Mucosal Resection (EMR). EMR is based on the concept that endoscopy (looking at the inside of your colon with an instrument called a colonoscope) provides visualization and access to the innermost lining of the gastrointestinal tract, where a polyp originates. The EMR performed during this study will be standard of care according to the current practice at University Hospitals of Cleveland.

Following polyp removal, the study procedure will be performed. A medical device is being evaluated to help with this procedure by closing the wound that remains after the polyp is removed without performing an open surgical operation. This involves suturing (sewing) the tissue back together with a Tissue Apposition System (TAS). This is also called tissue approximation. The sewing device being evaluated has been cleared by the FDA.

Up to 20 men and women, at least 21 years of age, requiring removal of a colonic or rectal polyp that cannot be removed by traditional colonic polypectomy, will be asked to enroll in the study. Following polyp removal, these patients will have the remaining tissue area closed using the study sewing device. Participation in this study will last approximately three months.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 21 years of age;
Willing to give consent and comply with evaluation and treatment schedule;
Approved for polypectomy per standard preoperative endoscopic evaluation;
Established indication for a procedure greater than colonoscopy and colonic polypectomy. This will include polyps not suitable for current practice (snare procedure) endoscopic resection by nature of size or location, in which an intestinal resection, laparoscopic-assisted polypectomy is required;
Surgical area viewable with laparoscopy.

Exclusion Criteria:

Physical or psychological condition which would impair study participation;
Unable or unwilling to attend follow-up visits and examinations;
Concurrent surgical procedure;
Pregnancy;
A polyp which appears to be an invasive cancer, even with negative pathology;
A polyp with biopsies suspicious for invasive cancer;
Participation in any other investigational device or drug study within 30 days prior to enrollment; or
Any condition which precludes compliance with the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553436

Locations

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

Sponsors and Collaborators

Ethicon Endo-Surgery

Investigators

Principal Investigator:

Conor P Delaney, MD MCh PhD FRCSI FACS

University Hospitals, Case Medical Center

More Information

No publications provided

Responsible Party:	Ethicon Endo-Surgery ( Susan Knippenberg )
Study ID Numbers:	CI-07-0004, UH IRB #07-07-08
Study First Received:	November 2, 2007
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00553436 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ethicon Endo-Surgery:

colon
rectum
polyp
EMR
Established indication for a procedure greater than colonoscopy and colonic polypectomy

Study placed in the following topic categories:

Polyps

ClinicalTrials.gov processed this record on May 06, 2009