CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis — CSALGI2  

Radiation Proctitis Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Proctitis
• Radiation Induced Proctitis
• Radiation Proctitis

• NCT number: NCT00756197
• Study type: Interventional
• Source: CSA Medical, Inc.
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2008
• Completion date: September 2009