Barrett's Esophagus
Conditions
Keywords
Barrett's esophagus dysplasia
Brief 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.
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.
Interventions
DEVICEPolar 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.
Sponsors
Chek-Med Systems, Inc.
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 98 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification | 12 months | The reduction of Barrett's segment length and histology classification will be measured at 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Barrett's Segment Length, Using the Prague Classification | 6 and 12 months | — |
| Assessment of Complications | 12 months | Specific complications are GI Bleeding and Perforation and Stricture and Ulceration |
| Assessment of Post-ablation Symptoms | 12 months | Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat |
| Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification | 6 months | The reduction of Barrett's segment length and histology classification will be measured at 6 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Polar Wand Treatment |
|---|---|
| Age, Continuous | 66 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: 12 months
Population: Terminated study. Enrollment much slower than anticipated and funding issues.
Secondary
Assessment of Complications
Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
Time frame: 12 months
Population: Terminated Study. Enrollment much slower than anticipated and funding issues
Secondary
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
Population: Terminated Study. Enrollment much slower than anticipated and funding issues.
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.
Time frame: 6 months
Population: Terminated Study. Enrollment much slower than anticipated and funding issues.
Secondary
Reduction in Barrett's Segment Length, Using the Prague Classification
Time frame: 6 and 12 months
Population: Terminated study. Enrollment much slower than anticipated and funding issues.