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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.

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.

Condition or disease Intervention/treatment Phase
Pressure Ulcers Device: DynaSense sensor Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Experimental: DynaSense sensor Device: DynaSense sensor



Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, California
El Camino Hospital
Mountain View, California, United States, 94040
Sponsors and Collaborators
Leaf Healthcare, Inc.
Centauri Medical, Inc.
Investigators
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Principal Investigator: Michelle Pezzani, MD El Camino Hospital

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Responsible Party: Leaf Healthcare, Inc.
ClinicalTrials.gov Identifier: NCT02005692     History of Changes
Other Study ID Numbers: CM-002
First Posted: December 9, 2013    Key Record Dates
Results First Posted: August 11, 2014
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by Leaf Healthcare, Inc.:
pressure ulcers
bed sores
patient turn protocol
patient movement
patient monitoring
Additional relevant MeSH terms:
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Pressure Ulcer
Skin Ulcer
Skin Diseases