ColoSeal™ ICD System Anastomotic Protection Pivotal Study
The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy.
Subject is 22-75 years of age at screening and is diagnosed with rectal cancer. [+7]
Subject at the time of baseline screening is not planned to have ostomy reversal... [+29]