Status:
COMPLETED
Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Barretts Esophagus
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (EGD) to ab...
Detailed Description
The Cryo-Ablator System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories to destroy tissue during surgical procedures by applying extreme cold. Patients will prepare ...
Eligibility Criteria
Inclusion
- Group 1:
- Co-morbid conditions such as severe heart, lung, kidney or liver disease.
- Refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy.
- Group 2:
- Patients with inoperable esophageal cancer (adenocarcinoma oe squamous cell CA) with lesions extending beyond the mucosa but limited to the esophageal wall
Exclusion
- Age less than 18 years
- Co-morbid illness expected to cause death within 6 months
- Pregnancy
- Refusal or inability to give consent
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00650988
Start Date
September 1 2005
End Date
December 1 2008
Last Update
December 24 2012
Active Locations (1)
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1
The Cleveland Clinic
Cleveland, Ohio, United States, 44195