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A Pilot Study to Assess the DynaSense System

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ClinicalTrials.gov Identifier: NCT02005692
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : August 11, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
Centauri Medical, Inc.
Information provided by (Responsible Party):
Leaf Healthcare, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Care Provider);   Primary Purpose: Supportive Care
Condition Pressure Ulcers
Intervention Device: DynaSense sensor
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DynaSense Sensor
Hide Arm/Group Description

All patients enrolled in the study were prescribed a Q2 hour (every 2 hour) turning protocol, as per the standard guidelines of the study site. In the context of the study, caregivers were not asked to turn patients any more or less frequently than what the study site's standard turning protocol required.

The rate of compliance with prescribed turning protocols was measured using the DynaSense System.

Period Title: Overall Study
Started 70
Completed 63
Not Completed 7
Reason Not Completed
Protocol Violation             1
Withdrawal by Subject             1
Discharged earlier than anticipated             5
Arm/Group Title DynaSense Sensor
Hide Arm/Group Description All subjects who successfully completed the study.
Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
All subjects who successfully completed the study.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 63 participants
63
(23 to 97)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
  47.6%
>=65 years
33
  52.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
35
  55.6%
Male
28
  44.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
American Indian or Alaska Native
5
   7.9%
Asian
7
  11.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
   7.9%
White
45
  71.4%
More than one race
0
   0.0%
Unknown or Not Reported
1
   1.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Hispanic or Latino
10
  15.9%
Not Hispanic or Latino
53
  84.1%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 63 participants
63
1.Primary Outcome
Title Safety Primary Endpoint
Hide Description The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.
Time Frame Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DynaSense Sensor
Hide Arm/Group Description:
All subjects enrolled in the study.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: percentage of subjects with ADEs
2.86
2.Primary Outcome
Title Turn Protocol Compliance
Hide Description The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.
Time Frame Subjects will be followed for the length of hospital stay which is expected to average 5 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DynaSense Sensor
Hide Arm/Group Description:
All subjects who successfully completed the study.
Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage turn compliance
98
(97 to 99)
Time Frame Upon removal of the patient sensor (within 5 minutes of removal), the subject’s skin was assessed for any ADEs.
Adverse Event Reporting Description If an ADE was present upon sensor removal, the subject’s skin was re-assessed approximately 1 hour later prior to hospital discharge when possible. If re-assessment was not possible prior to discharge, a follow-up telephone call was made to subjects to determine time to resolution.
 
Arm/Group Title DynaSense Sensor
Hide Arm/Group Description All subjects enrolled in the study.
All-Cause Mortality
DynaSense Sensor
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DynaSense Sensor
Affected / at Risk (%) # Events
Total   0/70 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DynaSense Sensor
Affected / at Risk (%) # Events
Total   2/70 (2.86%)    
Skin and subcutaneous tissue disorders   
Erythema (Skin Redness)  [1]  1/70 (1.43%)  1
Itching  [2]  1/70 (1.43%)  1
Skin Irritation/Discomfort  [3]  2/70 (2.86%)  2
Indicates events were collected by systematic assessment
[1]
Localized erythema (skin redness) following removal of patient sensor.
[2]
Localized itching in skin region where patient sensor was removed.
[3]
Skin irritation and discomfort following removal of patient sensor.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Barrett Larson, MD, Chief Medical Officer
Organization: Leaf Healthcare, Inc.
Phone: 650-701-3652
EMail: barrett.larson@leafhealthcare.com
Layout table for additonal information
Responsible Party: Leaf Healthcare, Inc.
ClinicalTrials.gov Identifier: NCT02005692     History of Changes
Other Study ID Numbers: CM-002
First Submitted: November 27, 2013
First Posted: December 9, 2013
Results First Submitted: July 19, 2014
Results First Posted: August 11, 2014
Last Update Posted: August 13, 2014