Healthy VolunteersNCT02265783
Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
A study testing Nellcor USB Pulse Oximeter Monitor Interface Cable in people with Healthy Volunteers, run by Medtronic - MITG at 1 site in United States.
Trial summary
The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Nellcor USB Pulse Oximeter Monitor Interface Cable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Nov 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects 18 or older (inclusive)
- Subject is able to participate for the duration of the study
- Subject is willing to sign an informed consent
Who cannot join
- Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors
- Physiologic abnormalities that prevent proper application of pulse oximetry sensor
- Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
Trial locations and contacts
1 site in 1 country.
United States1 site
Boulder Clinical Laboratory
Boulder, Colorado, 80301
About this study
The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims.
- Conditions
- Healthy Volunteers
- Being tested
- Nellcor USB Pulse Oximeter Monitor Interface Cable
- Keywords
- Focus of Study: Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nellcor USB Pulse Oximeter Monitor Interface CableDevice
Volunteers are subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature. Such conditions include exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.
| Study group | Role | What they receive |
|---|---|---|
| Nellcor USB Pulse Oximeter Monitor Interface Cable Sensor Test | Other | Not described Receives: Device: Nellcor USB Pulse Oximeter Monitor Interface Cable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed
A series of sensor-off events were collected from subjects in the study using marketed, off-the-shelf sensors. Each event was marked as pass if event duration (Timeend - Timestart) was less than or equal to 60 seconds; otherwise, the event was marked as greater than or equal to 60 seconds. The acceptance criteria is if 90% of the time the product posts Sensor Off, or any equal or higher priority alarm, within 60 seconds after sensor is removed.
Measured: 1 minute per event, multiple events per subject. Total duration up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionNov 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 Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Heyer, MD, Principal investigator, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265783
- Sponsor's protocol ID
- COVMOPR0461
- Status last verified
- Mar 2017
- First submitted
- 3 Oct 2014
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: The data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
- ClinicalTrials.gov ID
- NCT02265783
- Acronym / sponsor ID
- COVMOPR0461
- Conditions
- Healthy Volunteers
- Keywords
- Focus of Study: Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Posted 1 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nellcor USB Pulse Oximeter Monitor Interface Cable Sensor Test | Other | Device: Nellcor USB Pulse Oximeter Monitor Interface Cable |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female subjects 18 or older (inclusive)
- Subject is able to participate for the duration of the study
- Subject is willing to sign an informed consent
Key exclusion criteria (3 listed)
- Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors
- Physiologic abnormalities that prevent proper application of pulse oximetry sensor
- Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
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 |
|---|---|---|
| Nellcor USB Pulse Oximeter Monitor Interface CableVolunteers are subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature. Such conditions include exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket. | Device | Nellcor USB Pulse Oximeter Monitor Interface Cable Sensor Test |
Primary outcome
Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed
Time frame: 1 minute per event, multiple events per subject. Total duration up to 1 hour
A series of sensor-off events were collected from subjects in the study using marketed, off-the-shelf sensors. Each event was marked as pass if event duration (Timeend - Timestart) was less than or equal to 60 seconds; otherwise, the event was marked as greater than or equal to 60 seconds. The acceptance criteria is if 90% of the time the product posts Sensor Off, or any equal or higher priority alarm, within 60 seconds after sensor is removed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The data will not be shared.
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Screening Protocol
Pain
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.
Eric Heyer, MD principal investigator
Medtronic - MITG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nellcor USB Pulse Oximeter Monitor Interface Cable in people with Healthy Volunteers, run by Medtronic - MITG 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 3 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: finished, as of the sponsor's last update on 1 May 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?
Yes. Results are posted in the registry (first posted 1 May 2017). 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?
Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed (time frame: 1 minute per event, multiple events per subject. Total duration up to 1 hour). 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 1 May 2017.