Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy|
- Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS) [ Time Frame: At The Time of Surgery ] [ Designated as safety issue: No ]Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.
- Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition. [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]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.
- Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Experimental: Enrolled Subjects treated with TAS device
All enrolled subjects treated with the Tissue Apposition System (TAS) device
Device: Tissue Apposition System (TAS) Device
Closure of defect following polypectomy using the Tissue Apposition System (TAS) Device.
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.
|United States, Ohio|
|University Hospitals, Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Conor P Delaney, MD MCh PhD FRCSI FACS||University Hospital Case Medical Center|