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Trial NCT00553436

Resource URI: http://static.linkedct.org/resource/trials/NCT00553436
linkedct:brief_title Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
linkedct:condition <http://static.linkedct.org/resource/condition/10277>
linkedct: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.
linkedct: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). 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 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 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 21 Years
linkedct:end_date April 2009
linkedct:enrollment 5 (xsd:int)
linkedct:firstreceived_date November 2, 2007
linkedct:has_dmc No
linkedct:id NCT00553436
linkedct:intervention <http://static.linkedct.org/resource/intervention/34276>
rdfs:label Trial NCT00553436
linkedct:lastchanged_date June 24, 2009
linkedct:lead_sponsor_agency Ethicon Endo-Surgery
linkedct:location <http://static.linkedct.org/resource/location/182512>
linkedct:nct_id NCT00553436
linkedct:number_of_arms 1 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
linkedct:org_study_id CI-07-0004
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10477>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2938>
foaf:page <http://clinicaltrials.gov/show/NCT00553436>
linkedct:phase N/A
linkedct:primary_completion_date April 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/39792>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/39793>
linkedct:secondary_id UH IRB #07-07-08
linkedct:source Ethicon Endo-Surgery
linkedct:start_date November 2007
linkedct:study_design Treatment, Open Label, Single Group Assignment
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date June 2009