Clinical Trial: CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Single Center Pilot Study of CryoSpray Ablation(TM) to Determine Safety and Feasibility in Radiation Induced Proctitis (CSA LGI-2)

Brief Summary: The purpose of this study is to evaluate the safety, feasibility, tissue response, and subject side effects of liquid nitrogen sprayed through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") via endoscope in subjects with radiation induced proctitis.

Detailed Summary: The proposed study is a single center, ten patient pilot study to evaluate the safety and feasibility of sprayed liquid nitrogen through a catheter via endoscope in subjects with radiation proctitis. There will be two groups. Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy. Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.
Sponsor: CSA Medical, Inc.

Current Primary Outcome: The primary endpoints for this study are patient safety, treatment efficacy, and feasibility of cryospray therapy in subjects with radiation proctitis. [ Time Frame: End of Study ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The secondary endpoints for the study are the cataloging of side effects, and tissue response as determined by endoscopic visual evaluation. [ Time Frame: End of Study ]

Original Secondary Outcome: Same as current

Information By: CSA Medical, Inc.

Dates:
Date Received: September 18, 2008
Date Started: October 2008
Date Completion: September 2009
Last Updated: August 6, 2015
Last Verified: August 2015