Barrett's EsophagusNCT01477177
Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
A study testing Polar Wand carbon dioxide cryotherapy in people with Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 98 years
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- Polar Wand carbon dioxide cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
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.
Read the detailed description
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.
- Conditions
- Barrett's Esophagus
- Being tested
- Polar Wand carbon dioxide cryotherapy
- Keywords
- Barrett's esophagus dysplasia
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polar Wand carbon dioxide cryotherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Polar Wand Treatment | Experimental | Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia Receives: Device: Polar Wand carbon dioxide cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
Reduction in Barrett's Segment Length, Using the Prague Classification
Measured: 6 and 12 months
Assessment of Complications
Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
Measured: 12 months
Assessment of Post-ablation Symptoms
Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: enrollment much slower than anticipated, and, funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Chek-Med Systems, Inc.
- Responsible party
- Principal investigator, Herbert C. Wolfsen, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477177
- Sponsor's protocol ID
- 11-004237
- Status last verified
- Apr 2019
- First submitted
- 24 Oct 2011
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
- ClinicalTrials.gov ID
- NCT01477177
- Acronym / sponsor ID
- 11-004237
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's esophagus dysplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment much slower than anticipated, and, funding issues
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Chek-Med Systems, Inc.
- Study start
- Aug 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Posted 15 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polar Wand Treatment | Experimental | Device: Polar Wand carbon dioxide cryotherapyCryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia |
Who may qualify
- Ages
- 18 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polar Wand carbon dioxide cryotherapyPatients 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. | Device | Polar Wand Treatment |
Primary outcome
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.
4 secondary outcomes
Reduction in Barrett's Segment Length, Using the Prague Classification
Time frame: 6 and 12 months
Assessment of Complications
Time frame: 12 months
Assessment of Post-ablation Symptoms
Time frame: 12 months
Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polar Wand carbon dioxide cryotherapy in people with Barrett's Esophagus, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.