Status:
WITHDRAWN
CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis
Lead Sponsor:
CSA Medical, Inc.
Conditions:
Radiation Proctitis
Radiation Induced Proctitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 the...
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. ...
Eligibility Criteria
Inclusion
- Age 18 years of age
- Have radiation induced proctitis
Exclusion
- Pregnant or nursing
- Planning to become pregnant during the course of the study
- Planning to sire a child while enrolled in the study
- Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
- Subject has prior or concurrent ablation therapy including, but not limited to, photodynamic therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment, radio frequency, etc
- Refusal or inability to give consent.
- Concurrent chemotherapy.
- Medical contraindication or potential problem that would preclude study participation
- Concurrent participation in other experimental studies
- Uncontrolled coagulopathy or bleeding diathesis
- Portal hypertension due to cirrhosis manifest by esophageal, gastric or rectal varices
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00756197
Start Date
October 1 2008
End Date
September 1 2009
Last Update
August 7 2015
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