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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
Sponsor:
Collaborator:
Centauri Medical, Inc.
Information provided by (Responsible Party):
Leaf Healthcare, Inc.

Tracking Information
First Submitted Date  ICMJE November 27, 2013
First Posted Date  ICMJE December 9, 2013
Results First Submitted Date  ICMJE July 19, 2014
Results First Posted Date  ICMJE August 11, 2014
Last Update Posted Date August 13, 2014
Study Start Date  ICMJE December 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
  • 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.
  • Efficacy Primary Endpoint [ 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 measure the rate of compliance with prescribed patient turning protocols by using the DynaSense system.
Change History Complete list of historical versions of study NCT02005692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
Secondary Efficacy Clinical Endpoint [ Time Frame: Subjects will be followed for the length of hospital stay which is expected to average 5 days. ]
The secondary efficacy clinical endpoint is to measure the severity of non-compliance with turning protocols, which is a measure which reflects the average amount of time that turns are past due.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study to Assess the DynaSense System
Official Title  ICMJE A Pilot Study to Assess the DynaSense System
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE Pressure Ulcers
Intervention  ICMJE Device: DynaSense sensor
Study Arms  ICMJE Experimental: DynaSense sensor
Intervention: Device: DynaSense sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2013)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult male or female 18 to 110 years of age;
  • Inpatient currently on the unit and expected to remain for at least 12 hours;
  • Able and willing to comply with the study procedures;
  • Subject (or his/her agent) is able to read, understand, and provide Informed Consent in the English language.

Exclusion Criteria:

  • Subject is a female subject under the age of 60 who is pregnant, planning on becoming pregnant, or is currently breastfeeding.

    1. Any woman under the age of 60, must have a negative urine pregnancy test prior to being enrolled in the study; OR
    2. Be postmenopausal for at least 2 years, OR
    3. have had a bilateral tubal ligations, OR
    4. have had a bilateral oophorectomy, OR
    5. have had a hysterectomy.
  • Subjects with a known tape allergy or sensitivity to EKG leads or similar types of adhesives used in common medical products.
  • Subjects who cannot have the patient sensor applied on the surface of the patient's anterior torso.
  • Subjects who have a pacemaker or implantable cardiovascular-defibrillator (ICD).
  • Subjects with dementia, Alzheimer's disease or other mental disabilities and incapacitation that would prevent the subject from providing written informed consent. If the subject is unable to provide informed consent due to mental incapacity, then the subject's Durable Power of Attorney may provide informed consent and sign the informed consent on behalf of the subject.
  • Subjects who refuse to have an area of hair on their chest be clipped or shaved, if needed for patient sensor adhesion.
  • Subjects, who in the opinion of the Principal Investigator, are at increased risk by participating in the clinical study.
  • Subjects who have participated in another clinical study within the past 30 days or are currently participating in another clinical study at the time of screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02005692
Other Study ID Numbers  ICMJE CM-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leaf Healthcare, Inc.
Study Sponsor  ICMJE Leaf Healthcare, Inc.
Collaborators  ICMJE Centauri Medical, Inc.
Investigators  ICMJE
Principal Investigator: Michelle Pezzani, MD El Camino Hospital
PRS Account Leaf Healthcare, Inc.
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP