NCT00756197

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: CSA Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Radiation Proctitis
• Radiation Induced Proctitis

Interventions

Type	Name	Description
DEVICE	Cryo Spray Ablation Group 1	Cryo Spray Ablation
DEVICE	Cryo Spray Ablation Group 2	cryo spray ablation

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-03-01
• Completion: 2009-09-01
• First posted: 2008-09-22
• Last updated: 2015-08-07