Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
Stopped: enrollment much slower than anticipated, and, funding issues
United States4 participantsStarted 2011-08
Plain-language summary
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.
Who can participate
Age range
18 Years – 98 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients referred for treatment with Barrett's esophagus with dysplasia as the original indication for ablative treatment.
* Previous fundoplication surgery is permitted
* Age 18 years to 98 years
* Ability to provide written, informed consent
Exclusion Criteria:
* Inability to obtain biopsies due to anticoagulation, varices, etc.
* Previous ablation therapy, wide area mucosal resection or external beam radiation to the thorax.
* Intolerance to twice daily proton pump inhibitor medication or inability to undergo sedation or endoscopic procedures.
* Worse than Grade B erosive esophagitis
* Less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (resection).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification