Pressure UlcersNCT02005692
A Pilot Study to Assess the DynaSense System
A study testing DynaSense sensor in people with Pressure Ulcers, run by Leaf Healthcare, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- DynaSense sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- DynaSense sensor
- Keywords
- pressure ulcers, bed sores, patient turn protocol, patient movement, patient monitoring
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynaSense sensorDevice
| Study group | Role | What they receive |
|---|---|---|
| DynaSense sensor | Experimental | Not described Receives: Device: DynaSense sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Primary Endpoint
The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.
Measured: 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.
Measured: Subjects will be followed for the length of hospital stay which is expected to average 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leaf Healthcare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centauri Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Michelle Pezzani, MD, Principal investigator, El Camino Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005692
- Sponsor's protocol ID
- CM-002
- Status last verified
- Aug 2014
- First submitted
- 27 Nov 2013
- Last updated
- 13 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the DynaSense System
- ClinicalTrials.gov ID
- NCT02005692
- Acronym / sponsor ID
- CM-002
- Conditions
- Pressure Ulcers
- Keywords
- pressure ulcers, bed sores, patient turn protocol, patient movement, patient monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Leaf Healthcare, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centauri Medical, Inc.
- Study start
- Dec 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 11 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DynaSense sensor | Experimental | Device: DynaSense sensor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Subject is a female subject under the age of 60 who is pregnant, planning on becoming pregnant, or is currently breastfeeding.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DynaSense sensor | Device | DynaSense sensor |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Pezzani, MD principal investigator
El Camino Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DynaSense sensor in people with Pressure Ulcers, run by Leaf Healthcare, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.