Status:
TERMINATED
A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy
Lead Sponsor:
CSA Medical, Inc.
Conditions:
Barrett's Esophagus
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The primary objective of this study is to determine the percentage segment regression after spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's Esophagus (BE) ...
Detailed Description
This is an adaptive dose-escalation clinical trial using trūFreeze™ spray cryotherapy for the treatment of dysplastic Barrett's Esophagus in a clinical setting. Participants will be enrolled in cohor...
Eligibility Criteria
Inclusion
- English speaking males or females aged 18 to 80 who are candidates for sedated endoscopy with treatment of BE.
- At least 3 centimeters segment length of Barrett's Esophagus (BE) with or without circumferential involvement (i.e. CxM3) and with high grade or low grade dysplasia based on pathology results from 4 quadrant biopsies taken every 1-2 centimeter throughout the BE. All readings of dysplasia will be confirmed by an expert pathologist.
- Willing to undergo spray cryotherapy and judged by patient's physician as an appropriate candidate for this therapy.
- Able to read, comprehend, and complete the informed consent form
Exclusion
- Bleeding disorder or other contraindication of spray cryotherapy.
- History of partial or complete esophagectomy.
- Current or past diagnosis of invasive esophageal cancer (previous intramucosal cancer is allowable, if removed by endoscopic mucosal resection with histologically confirmed negative lateral and deep margins).
- Pregnant women
- Contraindication to endoscopic spray cryotherapy as outlined in the directions for use for the device
- Previous endoscopic ablation treatment (such as radiofrequency ablation (RFA) or photodynamic therapy (PDT)).
- Previous chest external beam radiation therapy.
- Previous wide-area endoscopic resection or submucosal dissection. Previous focal mucosal resection is permitted (maximum 2 previous EMR's of 2cm or less removed representing less than 25% of the circumference of the esophagus removed).
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01845454
Start Date
April 1 2013
End Date
January 1 2015
Last Update
April 29 2016
Active Locations (6)
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1
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
2
University of Maryland
Baltimore, Maryland, United States, 21201
3
Columbia University
New York, New York, United States, 10032
4
University of North Carolina, Chapel Hill
Chapel Hil, North Carolina, United States, 27599