Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers
Completed · Early Phase 1
Conditions studied: Barretts Esophagus, Esophageal Cancer
In brief
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 ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.
Key facts
- Study ID
- NCT00650988
- Run by
- Case Comprehensive Cancer Center
- People needed
- 37
- Starts
- 2005-09-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2012-12-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Age less than 18 years
- Co-morbid illness expected to cause death within 6 months
- Pregnancy
- Refusal or inability to give consent
Where it is running
- The Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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