Ignite Creation Date:
2024-05-06 @ 1:04 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03923127
Status:
COMPLETED
Last Update Posted:
2020-08-28
First Post:
2019-04-17
Brief Title:
Transitional Care Study 3
Sponsor:
Philips Electronics Nederland BV acting through Philips CTO organization
Organization:
Philips Electronics Nederland BV acting through Philips CTO organization
Study Overview
Official Title:
PJ-013483 FLAGSHIP Transitional Care Study 3
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRICA
Brief Summary:
In this study patients with elective surgery will wear two devices HealthDot and Elan after surgery in hospital and after discharge at home for up to 2 weeks HealthDot or 3 weeks Elan The HealthDot will measure heart rate posture activity and respiratory rate which are stored on the device as well as sent to Philips The Elan device will measure PPG and accelerometer data which is transferred to Philips The data collected will be used for algorithm development Data will be analysed retrospectively and compared to readmission and adverse events to see if the events could have been predicted due to the collected data by the devices No clinical decisions will be based on the measurements done during the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None