Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
The purpose of this pilot study is to provide an initial assessment of the feasibility, safety and efficacy of Polar Wand carbon dioxide cryotherapy for treatment of Barrett's low grade and high grade dysplasia by use in a small number of patients so as to support, or otherwise, the development of a full-scale trial.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia|
- Reduction in Barrett's histology grade, using the modified Vienna classification [ Time Frame: 12 months ] [ Designated as safety issue: No ]The reduction of Barrett's segment length and histology classification will be measured at 12 months.
- Reduction in Barrett's segment length, using the Prague classification [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Assessment of complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
- Assessment of post-ablation symptoms [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat
- Reduction in Barrett's histology grade, using the modified Vienna classification [ Time Frame: 6 months ] [ Designated as safety issue: No ]The reduction of Barrett's segment length and histology classification will be measured at 6 months.
|Study Start Date:||August 2011|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Polar Wand Treatment
Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia
Device: Polar Wand carbon dioxide cryotherapy
Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.
Prospective pilot study to be performed in 14 Barrett's Esophagus patients with low grade and high grade dysplasia, referred for standard of care treatment. Patients will receive treatments with carbon dioxide Polar Wand cryotherapy at 0, 2 and 4 months, followed by surveillance endoscopy with four quadrant biopsies throughout the entire Barrett's esophagus (BE)segment at 6 months, followed by endoscopy with additional treatments (if needed) at 8 and 10 months, followed by a final surveillance endoscopy at 12 months, with four quadrant biopsies throughout the entire initial BE segment length.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477177
|United States, Florida|
|Jacksonville, Florida, United States, 32224|