Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy


NCT00250328

Interventional

Phase 1

Unknown status
The study involves adult subject requiring colonic anastomosis following laparoscopic intra-corporeal surgery. The anastomosis will be performed by using nitinilclip by the LapCAC device instead of staplers. Endpoints: safety-Functioning secured anastomosis and no occurrence of adverse event related to device use. The efficacy endpoint of this study includes clinical evaluation of characteristic parameters related to intestinal surgeries. Discharge day (or ready-for-discharge) Proven anastomotic leak rate (clinically or radiological) Stenosis / stricture at anastomosis Patient recovery level will be assessed every day during hospitalization and in the follow up visits.
Jan 31,2006
All
18 Years
90 Years
40

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