A Pilot Study to Assess the DynaSense System

Pressure Ulcers Clinical Trial

Official title:

A Pilot Study to Assess the DynaSense System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005692
• Other study ID #: CM-002
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: August 10, 2014
• Start date: December 2013
• Est. completion date: February 2014

Study information

• Verified date: August 2014
• Source: Leaf Healthcare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers

Intervention

Device:
• DynaSense sensor

Locations

Country	Name	City	State
United States	El Camino Hospital	Mountain View	California

Sponsors (2)

Lead Sponsor	Collaborator
Leaf Healthcare, Inc.	Centauri Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Primary Endpoint	The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.	Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.	Yes
Primary	Turn Protocol Compliance	The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.	Subjects will be followed for the length of hospital stay which is expected to average 5 days.	No