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enrollment much slower than anticipated, and, funding issues
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| Name | Class |
|---|---|
| Chek-Med Systems, Inc. | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polar Wand Treatment | Experimental | Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polar Wand carbon dioxide cryotherapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Barrett's Segment Length, Using the Prague Classification | 6 and 12 months | |
| Assessment of Complications | Specific complications are GI Bleeding and Perforation and Stricture and Ulceration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Polar Wand Treatment | Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Polar Wand Treatment | Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Terminated study. Enrollment much slower than anticipated and funding issues. | Posted | 12 months |
|
Adverse Events were collected for 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Polar Wand Treatment | Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Herbert C. Wolfsen, M.D. | Mayo Clinic | 904-953-6319 | Wolfsen.Herbert@mayo.edu |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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|
| 12 months |
| Assessment of Post-ablation Symptoms | Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat | 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. | 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Reduction in Barrett's Segment Length, Using the Prague Classification | Terminated study. Enrollment much slower than anticipated and funding issues. | Posted | 6 and 12 months |
|
|
| Secondary | Assessment of Complications | Specific complications are GI Bleeding and Perforation and Stricture and Ulceration | Terminated Study. Enrollment much slower than anticipated and funding issues | Posted | 12 months |
|
|
| Secondary | Assessment of Post-ablation Symptoms | Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat | Terminated Study. Enrollment much slower than anticipated and funding issues. | Posted | 12 months |
|
|
| Secondary | 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. | Terminated Study. Enrollment much slower than anticipated and funding issues. | Posted | 6 months |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D004066 |
| Digestive System Diseases |