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

Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553436
• Other study ID #: CI-07-0004
• Secondary ID: UH IRB #07-07-08
• Status: Completed
• Phase: N/A
• First received: November 2, 2007
• Last updated: April 20, 2010
• Start date: November 2007
• Est. completion date: April 2009

Study information

• Verified date: April 2010
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polyps

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals, Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS)	Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.	At The Time of Surgery	No
Secondary	Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition.	The total number of participants with successful deployments of tissue anchors and associated knotting elements for tissue closure post-Endoscopic Mucosal Resection (EMR) tissue apposition and achieving defect closure.	3 month follow-up	No
Secondary	Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition		3 month follow-up	No