Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
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|ClinicalTrials.gov Identifier: NCT01477177|
Recruitment Status : Terminated (enrollment much slower than anticipated, and, funding issues)
First Posted : November 22, 2011
Last Update Posted : April 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Barrett's Esophagus||Device: Polar Wand carbon dioxide cryotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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.
- Reduction in Barrett's histology grade, using the modified Vienna classification [ Time Frame: 12 months ]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 ]
- Assessment of complications [ Time Frame: 12 months ]Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
- Assessment of post-ablation symptoms [ Time Frame: 12 months ]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 ]The reduction of Barrett's segment length and histology classification will be measured at 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477177
|United States, Florida|
|Jacksonville, Florida, United States, 32224|