An interventional study of Polar Wand carbon dioxide cryotherapy in Barrett's Esophagus, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 98 Years. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
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.
316 studies on the registry are indexed under Barrett Esophagus; 62 are open to participants now.
This study's enrollment of 4 is below the median of 61 across 190 interventional studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
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Exclusion Criteria:
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
The reduction of Barrett's segment length and histology classification will be measured at 12 months.
Time frame: 12 months
Reduction in Barrett's Segment Length, Using the Prague Classification
Time frame: 6 and 12 months
Assessment of Complications
Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
Time frame: 12 months
Assessment of Post-ablation Symptoms
Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat
Time frame: 12 months
Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification
The reduction of Barrett's segment length and histology classification will be measured at 6 months.
Time frame: 6 months
| Milestone | Polar Wand Treatment |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
The reduction of Barrett's segment length and histology classification will be measured at 12 months.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
No measurements were reported for this outcome.
Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat
No measurements were reported for this outcome.
The reduction of Barrett's segment length and histology classification will be measured at 6 months.
No measurements were reported for this outcome.
Collected over Adverse Events were collected for 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Polar Wand Treatment | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(years) | Polar Wand Treatment |
|---|---|
| Mean | 66 (61 to 71) |
| Sex: Female, Male(Participants) | Polar Wand Treatment |
|---|---|
| Female | 0 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Polar Wand Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Polar Wand Treatment |
|---|---|
| United States | 4 |
The record gives a start of Aug 2011, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
Results were first posted in May 2019, 5 years 1 month after primary completion.
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This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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