Polyps Clinical Trial
Official title:
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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