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

NCT00756197 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-08-07

No results posted yet for this study

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.

Conditions

  • Radiation Proctitis
  • Radiation Induced Proctitis

Interventions

DEVICE

Cryo Spray Ablation Group 1

Cryo Spray Ablation

DEVICE

Cryo Spray Ablation Group 2

cryo spray ablation

Sponsors & Collaborators

  • CSA Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Mary Lee Krinsky, D.O. · VA San Diego Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-03-31
Completion
2009-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00756197 on ClinicalTrials.gov