Clinical trial · Interventional
Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): enrollment much slower than anticipated, and, funding issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polar Wand carbon dioxide cryotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Polar Wand Treatment
- description
- Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia
- interventionNames
- Device: Polar Wand carbon dioxide cryotherapy
Primary outcomes (1)
- measure
- Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification
- timeFrame
- 12 months
- description
- The reduction of Barrett's segment length and histology classification will be measured at 12 months.
Secondary outcomes (4)
- measure
- Reduction in Barrett's Segment Length, Using the Prague Classification
- timeFrame
- 6 and 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 98 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available