Status:
COMPLETED
Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.
Lead Sponsor:
CSA Medical, Inc.
Collaborating Sponsors:
University of Miami
Conditions:
Barrett's Esophagus
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA"...
Detailed Description
The proposed study is a single center study consisting of no more than 10 subjects who are undergoing scheduled esophagectomy for reasons unrelated to the study. Subjects will be divided into 2 Groups...
Eligibility Criteria
Inclusion
- Age 18 years of age
- Esophagectomy planned based on clinical situation not related to this study.
- Deemed operable based on institutional criteria.
Exclusion
- Pregnant
- Esophageal stricture preventing passage of endoscope or catheter.
- 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.
- Refusal or inability to give consent.
- Concurrent chemotherapy.
- Prior or concurrent endoscopic ablation therapy within 4 cm from the CSA treatment area including, but not limited to, cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation, or argon plasma coagulation.
- Prior radiation therapy which involved the esophagus.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00754468
Start Date
February 1 2009
End Date
March 1 2012
Last Update
November 4 2015
Active Locations (1)
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1
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136