A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy
Stopped early · Not applicable
Conditions studied: Barrett's Esophagus
In brief
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) using trūFreeze™ spray cryotherapy within the currently recommended therapeutic range. Secondary objectives are the determination of safety related outcomes such as esophageal stricture.
Key facts
- Study ID
- NCT01845454
- Run by
- CSA Medical, Inc.
- People needed
- 36
- Starts
- 2013-04-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2016-04-29
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States
- University of Maryland — Baltimore, Maryland, United States
- Columbia University — New York, New York, United States
- University of North Carolina, Chapel Hill — Chapel Hil, North Carolina, United States
- Ahuja/University Hospitals — Beachwood, Ohio, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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