Trial Outcomes & Findings for Study of a New Clinical Device for Reducing Body Core Temperature (NCT NCT01996982)
NCT ID: NCT01996982
Last Updated: 2019-07-29
Results Overview
1. Assess and capture all adverse events (if any) from application and use of the CCS device. 2. Also assess CCS device interference with participant's standard of care.
TERMINATED
NA
7 participants
1 year after the enrollment is closed
2019-07-29
Participant Flow
No data, beyond protocol enrollment number, are available for this study as the Principal Investigator (PI) has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, however, no data are available
Participant milestones
| Measure |
Device
CCS Device application
CCS Device: Core Cooling System Device
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Device
CCS Device application
CCS Device: Core Cooling System Device
|
|---|---|
|
Overall Study
PI/team left institution
|
7
|
Baseline Characteristics
Study of a New Clinical Device for Reducing Body Core Temperature
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 1 year after the enrollment is closedPopulation: No data are available for this study as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, however, no data are available.
1. Assess and capture all adverse events (if any) from application and use of the CCS device. 2. Also assess CCS device interference with participant's standard of care.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year after the enrollment is closed.Population: No data are available for this study as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, however, no data are available.
Assess and capture all adverse events from induction of TH with CCS device.
Outcome measures
Outcome data not reported
Adverse Events
Device
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