Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy

NCT ID: NCT00553436

Last Updated: 2010-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-04-30

Brief Summary

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.

Detailed Description

Polypectomy is the medical term for removing polyps. Polyps are abnormal like growths that protrude into the lining of the bowel. Because a polyp 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). Endoscopic Mucosal Resection (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 Endoscopic Mucosal Resection (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 Food and Drug Administration (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.

Conditions

Polyps

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enrolled Subjects treated with TAS device

All enrolled subjects treated with the Tissue Apposition System (TAS) device

Group Type: EXPERIMENTAL

Tissue Apposition System (TAS) Device

Intervention Type: DEVICE

Closure of defect following polypectomy using the Tissue Apposition System (TAS) Device.

Interventions

Tissue Apposition System (TAS) Device

Closure of defect following polypectomy using the Tissue Apposition System (TAS) Device.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Ethicon Endo-Surgery

Principal Investigators

Conor P Delaney, MD MCh PhD FRCSI FACS

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals, Case Medical Center

Cleveland, Ohio, United States

Countries

United States

References

Agrawal D, Chak A, Champagne BJ, Marks JM, Delaney CP. Endoscopic mucosal resection with full-thickness closure for difficult polyps: a prospective clinical trial. Gastrointest Endosc. 2010 May;71(6):1082-8. doi: 10.1016/j.gie.2009.12.036.

Reference Type: DERIVED

PMID: 20438900 (View on PubMed)

Other Identifiers

UH IRB #07-07-08

Identifier Type: -

Identifier Source: secondary_id

CI-07-0004

Identifier Type: -

Identifier Source: org_study_id