A Pilot Study to Assess the DynaSense System

Leaf Healthcare, Inc.1 site in 1 country70 target enrollmentDecember 2013

ConditionsPressure Ulcers

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pressure Ulcers
Sponsor: Leaf Healthcare, Inc.
Enrollment: 70
Locations: 1
Primary Endpoint: Safety Primary Endpoint
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

February 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Leaf Healthcare, Inc.

Responsible Party

Sponsor

Eligibility 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.
•Any woman under the age of 60, must have a negative urine pregnancy test prior to being enrolled in the study; OR
•Be postmenopausal for at least 2 years, OR
•have had a bilateral tubal ligations, OR
•have had a bilateral oophorectomy, OR
•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.