Status:
UNKNOWN
Endoesophageal Cryotherapy For Ablating Barrett's Esophagus and Early Stage Esophageal Cancer
Lead Sponsor:
Walter Reed Army Medical Center
Collaborating Sponsors:
CSA Medical, Inc.
Conditions:
Barrett's Esophagus
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
In this prospective single center study, up to 25 patients with Barrett's esophagus with LGD or no dysplasia (Group 1), 25 patients with HGD/IMCA (Group 2), 25 patients with esophageal carcinoma confi...
Detailed Description
Baseline evaluation will include the following ( all are considered standard of care except # 8 ): 1. Informed consent. 2. Evaluation of inclusion/exclusion criteria 3. Demographics- date of birth, a...
Eligibility Criteria
Inclusion
- \*\* You must be eligible for care within the Department of Defense (DEERS eligible) to be enrolled into this protocol \*\*
- Per Groups 1,2,3,4 (above)
- Specifically:
- Diagnosis of specialized intestinal metaplasia (Barrett's esophagus) with either low grade, indeterminate or no dysplasia (Group 1)
- high grade or intramucosal cancer and deemed inoperable based on co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention; CT scan and EUS demonstrating no evidence of trans-mural tumor or lymph node involvement; pathology review of esophageal biopsies by 2 independent reviewers to include 1 from the Walter Reed Army Medical Center Pathology Department; presentation at tumor board (Group 2)
- T1smN0 or T2NO adenocarcinoma arising in Barrett's esophagus and all criteria as for group 2 (Group 3)
- diagnosis of severe squamous dysplasia and all criteria as for group 2 (Group 4)
Exclusion
- Not eligible for care within the Department of Defense medical system
- Age less than 18 years or greater then 85 years (at time of entry)
- Co-morbid illness expected to cause death within 6 months
- Pregnancy (as determined by urine HCG)
- Medically unfit or other contraindications to tolerate upper endoscopy
- Inability to tolerate therapy with a proton pump inhibitor
- Refusal or inability to give consent
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00628784
Start Date
March 1 2007
End Date
March 1 2012
Last Update
July 24 2008
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307