Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04892914
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2021-05-11
Brief Title:
Embr Thermal Device for Hot Flash Management in Prostate Cancer
Sponsor:
Embr Labs Inc
Organization:
Embr Labs Inc
Study Overview
Official Title:
Feasibility of the Embr Thermal Device for Management of Hot Flashes in Men With Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2022-04
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:
None
Brief Summary:
This study is being conducted to evaluate if the Embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment
Detailed Description:
The Embr thermal device is a smart device that is worn on the inside of the wrist It is about the size of a smart watch The Embr thermal device produces cooling or warming temperature sensations that make some people feel slightly cooler or warmer This objective of this study is to evaluate if the Embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment The study will take place over 4 weeks The primary outcome is feasibility of the Embr thermal device in men with prostate cancer Secondary outcomes include preliminary efficacy of the device which will include the change in hot flash interference sleep measures sleep impairment and fatigue This is a remote study--all study assessments will be completed electronically
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