Trial Outcomes & Findings for Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus (NCT NCT01477177)
NCT ID: NCT01477177
Last Updated: 2019-05-15
Results Overview
The reduction of Barrett's segment length and histology classification will be measured at 12 months.
TERMINATED
NA
4 participants
12 months
2019-05-15
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
Baseline characteristics by cohort
| Measure |
Polar Wand Treatment
n=4 Participants
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.
|
|---|---|
|
Age, Continuous
|
66 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Terminated study. Enrollment much slower than anticipated and funding issues.
The reduction of Barrett's segment length and histology classification will be measured at 12 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Terminated study. Enrollment much slower than anticipated and funding issues.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Terminated Study. Enrollment much slower than anticipated and funding issues
Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Terminated Study. Enrollment much slower than anticipated and funding issues.
Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Terminated Study. Enrollment much slower than anticipated and funding issues.
The reduction of Barrett's segment length and histology classification will be measured at 6 months.
Outcome measures
Outcome data not reported
Adverse Events
Polar Wand Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place