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

Completed · Not applicable

Conditions studied: Polyps

In brief

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.

Key facts

Study ID

NCT00553436

Run by

Ethicon Endo-Surgery

People needed

7

Starts

2007-11-01

Expected to finish

2009-04-01

Last updated by the study team

2010-04-27

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Hospitals, Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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