Clinical Trials

This investigation constitutes an initial evaluation of the stoma occlusion device in humans with a mature permanent Brooke ileostomy. The overall objective of this study is to assess feasibility and initial operating characteristics of a novel stoma occlusion device. The study will recruit 20 patients for placement of the device into the mature Brooke ileostomy and subsequent 2 hour observation period. The device will remain in the ileostomy for up to 2 hours.

The purpose of this study is to assess the immediate outcomes associated with early closure of diverting loop ileostomy.  In addition, days to return to work will be calculated.