Vital SignsVSPNCT02521922
Vital Signs Patch Early Feasibility and Usability Study
A study testing VSP System - NEHB Configuration and VSP System - PAL Configuration in people with Vital Signs, run by LifeWatch Services, Inc. at 1 site in United States.
Trial summary
To assess the feasibility and usability of the VSP System in the in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be incorporated into the study site's Information Technology infrastructure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vital Signs
- What is being tested?
- VSP System - NEHB Configuration and VSP System - PAL Configuration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2014to 1 Apr 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male and female in-patients with vital signs considered 'stable' by clinical caregivers.
Who cannot join
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest.
- Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc.
- Patients in the Critical Care Unit (CCU)
- Patients who otherwise satisfy any of the contraindications associated with the VSP system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
To assess the feasibility and usability of the VSP System in the in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be incorporated into the study site's Information Technology infrastructure.
Read the detailed description
The primary objective of this clinical feasibility study is to evaluate the feasibility of the Vital Signs Patch System (VSP). The VSP will be incorporated into the study site's Information Technology infrastructure and worn by in-patients for a minimum of 3 days and for the duration of their hospital stay up to 7 days.
The VSP will take and monitor vital signs in addition to the normal equipment the facility uses to monitor and take vital signs. This study will not be assessing safety and no comparator groups will be used. As this study will not be treating any particular disease or condition, no randomization or blinding is required. Subjects will be chosen as they are admitted in accordance with the general population characteristics, inclusion and exclusion criteria and willingness to sign the Informed Consent.
This clinical study involves a device with no additional drugs administered.
During this study, a single VSP System patch will be worn for up to 48 hours. The first patch will be placed using the NEHB configuration. After the first 48 hours, the NEHB-configured patch will be replaced with a new patch in the PAL configuration. The second patch can remain on the subject for the duration of the subject's hospital stay, or up to seven (7) consecutive days. Individual patient use will determine the duration of time that the second patch can be worn.
- Conditions
- Vital Signs
- Being tested
- VSP System - NEHB Configuration, VSP System - PAL Configuration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSP System - NEHB ConfigurationDevice
VSP System - NEHB Configuration will take and record participant vital signs. NEHB is the last name of the physician who developed the configuration. It is not an acronym.
VSP System - PAL ConfigurationDevice
VSP System - PAL Configuration will take and record patient vital signs. PAL is the name created by the engineering team of this device. It is not an acronym.
| Study group | Role | What they receive |
|---|---|---|
| VSP Study Participants | Experimental | Vital Signs Patch system study participants. Each study participant will receive the VSP System - NEHB Configuration and then the VSP System - PAL Configuration. Vital signs will be taken and adhesive will be assessed for each participant for each configuration. Receives: Device: VSP System - NEHB Configuration; Device: VSP System - PAL Configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Outcome Measure - 100% Successful Vital Signs Acquisition
Successful acquisition of Temperature, Heart Rate, ECG, Respiration, and SpO2 daily for the inpatient stay of the subject up to seven days. Success is achieved if all vital signs are obtained on a study participant. It is a composite result.
Measured: Up to seven days
Secondary outcomes (1)
Composite Outcome Measure - Adhesive Performance - Measurement of skin irritation resulting from adhesive used with electrodes.
Successful performance of the adhesive of the patch throughout the study for each subject. Subject skin will be checked daily to determine if irritation has resulted where the electrodes have been placed. The results will be either positive or negative for skin irritation. This is a composite outcome measure.
Measured: Up to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start16 Apr 2014
- Primary completion9 Jun 2016
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeWatch Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, M.D., Principal investigator, Mt. Sinai Medical CenterMarie Noelle-Langan, M.D., Principal investigator, Mt. Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521922
- Sponsor's protocol ID
- VSP-F001v1.2
- Acronym
- VSP
- Status last verified
- Mar 2017
- First submitted
- 10 Aug 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
- ClinicalTrials.gov ID
- NCT02521922
- Acronym / sponsor ID
- VSP / VSP-F001v1.2
- Conditions
- Vital Signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- LifeWatch Services, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2014
- Primary completion
- 9 Jun 2016 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 13 Aug 2015 (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.
To assess the feasibility and usability of the VSP System in the in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be incorporated into the study site's Information Technology infrastructure.
Detailed description
The primary objective of this clinical feasibility study is to evaluate the feasibility of the Vital Signs Patch System (VSP). The VSP will be incorporated into the study site's Information Technology infrastructure and worn by in-patients for a minimum of 3 days and for the duration of their hospital stay up to 7 days.
The VSP will take and monitor vital signs in addition to the normal equipment the facility uses to monitor and take vital signs. This study will not be assessing safety and no comparator groups will be used. As this study will not be treating any particular disease or condition, no randomization or blinding is required. Subjects will be chosen as they are admitted in accordance with the general population characteristics, inclusion and exclusion criteria and willingness to sign the Informed Consent.
This clinical study involves a device with no additional drugs administered.
During this study, a single VSP System patch will be worn for up to 48 hours. The first patch will be placed using the NEHB configuration. After the first 48 hours, the NEHB-configured patch will be replaced with a new patch in the PAL configuration. The second patch can remain on the subject for the duration of the subject's hospital stay, or up to seven (7) consecutive days. Individual patient use will determine the duration of time that the second patch can be worn.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VSP Study Participants | Experimental | Device: VSP System - NEHB Configuration, Device: VSP System - PAL ConfigurationVital Signs Patch system study participants. Each study participant will receive the VSP System - NEHB Configuration and then the VSP System - PAL Configuration. Vital signs will be taken and adhesive will be assessed for each participant for each configuration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult male and female in-patients with vital signs considered 'stable' by clinical caregivers.
Key exclusion criteria (7 listed)
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest.
- Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc.
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 |
|---|---|---|
| VSP System - NEHB ConfigurationVSP System - NEHB Configuration will take and record participant vital signs. NEHB is the last name of the physician who developed the configuration. It is not an acronym. | Device | VSP Study Participants |
| VSP System - PAL ConfigurationVSP System - PAL Configuration will take and record patient vital signs. PAL is the name created by the engineering team of this device. It is not an acronym. | Device | VSP Study Participants |
Primary outcome
Composite Outcome Measure - 100% Successful Vital Signs Acquisition
Time frame: Up to seven days
Successful acquisition of Temperature, Heart Rate, ECG, Respiration, and SpO2 daily for the inpatient stay of the subject up to seven days. Success is achieved if all vital signs are obtained on a study participant. It is a composite result.
1 secondary outcome
Composite Outcome Measure - Adhesive Performance - Measurement of skin irritation resulting from adhesive used with electrodes.
Time frame: Up to seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
Vivek Reddy, M.D. principal investigator
Mt. Sinai Medical Center
Marie Noelle-Langan, M.D. principal investigator
Mt. Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSP System - NEHB Configuration and VSP System - PAL Configuration in people with Vital Signs, run by LifeWatch Services, 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 1 inclusion and 7 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 4 Apr 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite Outcome Measure - 100% Successful Vital Signs Acquisition (time frame: Up to seven days). 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 4 Apr 2017.