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

Study Overview
=================
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.

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

Conditions
-----------------
Polyps

Intervention / Treatment
-----------------
* Device: Tissue Apposition System (TAS) Device


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enrolled Subjects treated with TAS device<br>All enrolled subjects treated with the Tissue Apposition System (TAS) device | Device: Tissue Apposition System (TAS) Device<br>* Closure of defect following polypectomy using the Tissue Apposition System (TAS) Device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition |  | 3 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon, rectum, polyp, EMR, Established indication for a procedure greater than colonoscopy and colonic polypectomy