Trial Outcomes & Findings for Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects (NCT NCT01681745)
NCT ID: NCT01681745
Last Updated: 2024-01-24
Results Overview
The biological response of the treated tissue by the Cryo-Touch III or Cryo-Touch IV device was determined through gross pathology and histological assessment.
COMPLETED
NA
30 participants
7 days
2024-01-24
Participant Flow
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Participant milestones
| Measure |
Cryo-Touch Treatment
Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.
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|---|---|
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 7 daysPopulation: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
The biological response of the treated tissue by the Cryo-Touch III or Cryo-Touch IV device was determined through gross pathology and histological assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
All anticipated observations, adverse events and SAEs/UADEs were assessed. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) were recorded.
Outcome measures
Outcome data not reported
Adverse Events
Cryo-Touch Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kent Jones/ Sr. Director Quality and Medical Affairs
Pacira Cryotech, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place