Post Surgical Pat., Medical Pat., Resp. Failure, Car.Arrest, DeathNCT00875602
Evaluation of EverOn™ - A Contact-Free System for Measuring Heart Rate, Respiratory Rate and Motion
A study testing EverOn (EarlySense) contactless monitoring device in people with Post Surgical Pat., Medical Pat., Resp. Failure, Car.Arrest, Death, run by EarlySense Ltd. at 1 site in United States.
Trial summary
Evaluation of continuous monitoring device on patients Risk during hospitalization and nurse satisfaction level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Surgical Pat., Medical Pat., Resp. Failure, Car.Arrest, Death
- What is being tested?
- EverOn (EarlySense) contactless monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Hospitalized patients
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of continuous monitoring device on patients Risk during hospitalization and nurse satisfaction level.
Read the detailed description
To assess the effects of continuous patient monitoring using a contactless monitor in a medical-surgical unit on transfers and length of stay at higher level of care units
- Being tested
- EverOn (EarlySense) contactless monitoring device
- Keywords
- All hospitalized patients in a general Med/ Surg unit
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverOn (EarlySense) contactless monitoring deviceDevice
Hospitalized patients on the study unit are monitored by a contactless device
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | before-after (retrospective) and concurrent controls as comparators with a prospective intervention group |
| Study unit | Active comparator | Hospitalized patients in the study group will be continously monitored / supervised by the contact-free device Receives: Device: EverOn (EarlySense) contactless monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of benefit to caregivers and patients
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startApr 2009
Why it stopped: NO need
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Surgical Pat., Medical Pat., Resp. Failure, Car.Arrest, DeathStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EarlySense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harvey V Brown, MD, Principal investigator, CHW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875602
- Sponsor's protocol ID
- CHW ES-MRK-PROT-6
- Status last verified
- Oct 2012
- First submitted
- 2 Apr 2009
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of EverOn™ - A Contact-Free System for Measuring Heart Rate, Respiratory Rate and Motion
- ClinicalTrials.gov ID
- NCT00875602
- Acronym / sponsor ID
- CHW ES-MRK-PROT-6
- Keywords
- All hospitalized patients in a general Med/ Surg unit
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NO need
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EarlySense Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- First posted
- 3 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of continuous monitoring device on patients Risk during hospitalization and nurse satisfaction level.
Detailed description
To assess the effects of continuous patient monitoring using a contactless monitor in a medical-surgical unit on transfers and length of stay at higher level of care units
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –before-after (retrospective) and concurrent controls as comparators with a prospective intervention group |
| Study unit | Active comparator | Device: EverOn (EarlySense) contactless monitoring deviceHospitalized patients in the study group will be continously monitored / supervised by the contact-free device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| EverOn (EarlySense) contactless monitoring deviceHospitalized patients on the study unit are monitored by a contactless device | Device | Study unit |
Primary outcome
Evidence of benefit to caregivers and patients
Time frame: 12 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
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.
Harvey V Brown, MD principal investigator
CHW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EverOn (EarlySense) contactless monitoring device in people with Post Surgical Pat., Medical Pat., Resp. Failure, Car.Arrest, Death, run by EarlySense Ltd. 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 6 Dec 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evidence of benefit to caregivers and patients (time frame: 12 month). 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 6 Dec 2016.