A Pilot Study to Assess the DynaSense System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02005692|
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : August 11, 2014
Last Update Posted : August 13, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcers||Device: DynaSense sensor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Study to Assess the DynaSense System|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
|Experimental: DynaSense sensor||
Device: DynaSense sensor
- Safety Primary Endpoint [ Time Frame: Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE. ]The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.
- Turn Protocol Compliance [ Time Frame: Subjects will be followed for the length of hospital stay which is expected to average 5 days. ]The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005692
|United States, California|
|El Camino Hospital|
|Mountain View, California, United States, 94040|
|Principal Investigator:||Michelle Pezzani, MD||El Camino Hospital|