Post Operative PatientNCT00640718
Evaluation of EverOn™ System in Medical / Surgical Ward
An observational study of Post Operative Patient and Patients Requiring PCA, run by EarlySense Ltd. at 1 site in United States.
Trial summary
The EverOn™ system developed by EarlySense, Ltd., the sponsor of this study, is intended to assist hospitals to better address and improve recognition and response to changes in a patient's condition. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post Operative Patient, Patients Requiring PCA, Respiratory Patients
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to May 2010
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults hospitalized in medical surgical units and are willing to sign consent form
Who may be able to join
- Age above 18 years.
- Patients not monitored continuously by telemetry, vital sign monitor or oximetry.
- Patients not requiring special mattresses (e.g. airflow).
- The patient or a legal guardian is ready to sign the Informed Consent.
Who cannot join
- Patients that at the judgment of the staff in the evaluating unit, are not able to communicate coherently and respond to nurses' questions.
- Patients monitored continuously by telemetry, vital sign monitor or oximetry.
- Patients requiring special mattresses.
Trial locations and contacts
1 site in 1 country.
United States1 site
MetroWest Medical Center
Framingham, Massachusetts, 01702-9167
About this study
Official title: Evaluation of EarlySense EverOn™ System in Medical / Surgical Ward
The EverOn™ system developed by EarlySense, Ltd., the sponsor of this study, is intended to assist hospitals to better address and improve recognition and response to changes in a patient's condition.
The system, monitors the patient while in bed consists of a contact-free sensor that is placed under the bed mattress and identifies respiratory and heart rates, degree of patient's movement or agitation while in bed as well as patient's actual exit out of the bed. The EverOn system does not require a physical contact with the patient, eliminating the need for any direct contact electrodes, leads, cuffs or nasal cannulae.
- Conditions
- Post Operative Patient, Patients Requiring PCA, Respiratory Patients, Patients in Risk of Fall
- Keywords
- heart and respiratory monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PatientStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EarlySense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640718
- Sponsor's protocol ID
- ES-MRK-PROT1.1
- Status last verified
- Mar 2008
- First submitted
- 17 Mar 2008
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of EarlySense EverOn™ System in Medical / Surgical Ward
- ClinicalTrials.gov ID
- NCT00640718
- Acronym / sponsor ID
- ES-MRK-PROT1.1
- Conditions
- Post Operative Patient, Patients Requiring PCA, Respiratory Patients, Patients in Risk of Fall
- Keywords
- heart and respiratory monitoring
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EarlySense Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 21 Mar 2008 (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.
The EverOn™ system developed by EarlySense, Ltd., the sponsor of this study, is intended to assist hospitals to better address and improve recognition and response to changes in a patient's condition.
The system, monitors the patient while in bed consists of a contact-free sensor that is placed under the bed mattress and identifies respiratory and heart rates, degree of patient's movement or agitation while in bed as well as patient's actual exit out of the bed. The EverOn system does not require a physical contact with the patient, eliminating the need for any direct contact electrodes, leads, cuffs or nasal cannulae.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults hospitalized in medical surgical units and are willing to sign consent form
Key inclusion criteria (4 listed)
- Age above 18 years.
- Patients not monitored continuously by telemetry, vital sign monitor or oximetry.
- Patients not requiring special mattresses (e.g. airflow).
- The patient or a legal guardian is ready to sign the Informed Consent.
Key exclusion criteria (3 listed)
- Patients that at the judgment of the staff in the evaluating unit, are not able to communicate coherently and respond to nurses' questions.
- Patients monitored continuously by telemetry, vital sign monitor or oximetry.
- Patients requiring special mattresses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 19 Jul 2016.
- Institute for Health Care Improvement (IHI)Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Patient and Patients Requiring PCA, 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 4 inclusion and 3 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 19 Jul 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.
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 19 Jul 2016.