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First received: April 12, 2023

Clinical Trial: Safety and Effectiveness Evaluations of the COLO-BT as an Treatment to the Proctectomy.

Study Status: Completed

Recruit Status: RECRUITING

Condition: Colorectal Surgery

Study Type: INTERVENTIONAL


Official Title: Safety and Effectiveness Evaluations of the COLO-BT™ (Colorectal Balloon Tube) as an Alternative Treatment to the Temporary Ileostomy Following Proctectomy.

Brief Summary: The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)

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