A Pilot Study to Assess the DynaSense System

NCT02005692 | Completed Results

• 1 other identifier: CM-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcers

Keywords

pressure ulcers; bed sores; patient turn protocol; patient movement; patient monitoring

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (1)

DynaSense sensor

EXPERIMENTAL

Device: DynaSense sensor

Interventions

DynaSense sensor DEVICE

DynaSense sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Leaf Healthcare, Inc.: lead
• Centauri Medical, Inc.: collaborator

Study Sites (1)

El Camino Hospital

Mountain View, California, 94040, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Barrett Larson, MD, Chief Medical Officer
• Organization: Leaf Healthcare, Inc.

barrett.larson@leafhealthcare.com

650-701-3652

Study Officials

• Michelle Pezzani, MD

  El Camino Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 9, 2013
• Study Start: December 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 13, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-08

Locations

US (1)