Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-02-22 @ 3:57 PM
Study NCT ID:
NCT02005692
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2013-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study to Assess the DynaSense System
Sponsor:
Leaf Healthcare, Inc.
Organization:
Study Overview
Official Title:
A Pilot Study to Assess the DynaSense System
Status:
COMPLETED
Status Verified Date:
2014-08
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:
None
Brief Summary:
The study is designed to test the DynaSense system, which is a patient movement and orientation monitoring system. The study is intended to determine that:
* the DynaSense system identifies patients that are not turning adequately on their own and therefore require caregiver-assisted turns.
* the DynaSense system identifies patients that are turning adequately on their own and therefore do not require a caregiver-assisted turn.
* the DynaSense system helps ensure compliance with an institution's established patient turning protocol.
* the DynaSense system identifies patients that are not turning adequately on their own and therefore require caregiver-assisted turns.
* the DynaSense system identifies patients that are turning adequately on their own and therefore do not require a caregiver-assisted turn.
* the DynaSense system helps ensure compliance with an institution's established patient turning protocol.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: