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COLO-BT Study
Protocol: STUDY00007567
Full Title
A Multicenter, Randomized, Open-Label, Non-Inferiority of the Safety and Effectiveness Evaluations of teh COLO-BT (Colorectal Balloon Tube) as an Alternative to the Temporary Ileostomy Following Proctectomy
Description
The University at Buffalo is looking for adults needing colorectal surgery for a clinical trial. The goal of this study is to investigate the safety and effectiveness of the COLO-BT (Colorectal Balloon Tube) device for people needing colon resection surgery.

Participants of this study will be randomly assigned (which happens by chance, like flipping a coin) to one of two groups: (1) will receive the COLO-BT device without stoma or (2) will receive the standard of care stoma. Participants will be enrolled in this study for up to 200 days after surgery. They will complete at least 7 study visits at the UBMD clinic (located in Williamsville). During study visits they will complete the following: have vital signs measured (such as temperature, blood pressure, and pulse rate); have bloodwork done; complete scans such as abdominal X-Rays and CT scans; and general maintenance of the COLO-BT device.
Compensation: No
Eligibility
Adults aged 19-80 years old Need colon (rectal) resection surgery
Age Group: Adults
Principal Investigator: Mark Falvo
Contact(s)
LYNN JAGODZINSKI
lynnjago@buffalo.edu
+1 716-888-4843
Chelsea Cowan
cacowan@buffalo.edu
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