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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Cryo Spray Ablation
cryo spray ablation
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
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
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