Evaluation of SpO2 PerformanceNCT03570255
Feasibility and Performance Evaluation for INVSENSOR00024
A study testing RD SET Neo SpO2 in people with Evaluation of SpO2 Performance, run by Masimo Corporation at 1 site in United States.
Trial summary
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. Read more about this study
- Who is it for?
- Ages Up to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Evaluation of SpO2 Performance
- What is being tested?
- RD SET Neo SpO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2018to 8 Nov 2019
- 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 Up to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Less than or equal to 1 month of age
- Weight <3kg
- Subjects admitted with standard of care (SOC) arterial blood sampling line already in place
Who cannot join
- Subjects with underdeveloped skin
- Subjects with abnormalities at the planned application sites that would interfere with system measurements
- Subjects with known allergic reactions to foam/rubber products and adhesive tape
- Deformities of limbs, absence of feet, sever edema, and other at the discretion of the Principal Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Feasibility and Performance Evaluation of INVSENSOR00024
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.
- Conditions
- Evaluation of SpO2 Performance
- Being tested
- RD SET Neo SpO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD SET Neo SpO2Device
All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.
| Study group | Role | What they receive |
|---|---|---|
| RD SET Neo SpO2 | Experimental | All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2. Receives: Device: RD SET Neo SpO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.
Measured: up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start25 Jun 2018
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
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 Evaluation of SpO2 PerformanceStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570255
- Sponsor's protocol ID
- HAMM0002
- Status last verified
- Feb 2020
- First submitted
- 15 Jun 2018
- Last updated
- 20 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Performance Evaluation of INVSENSOR00024
- ClinicalTrials.gov ID
- NCT03570255
- Acronym / sponsor ID
- HAMM0002
- Conditions
- Evaluation of SpO2 Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 20 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RD SET Neo SpO2 | Experimental | Device: RD SET Neo SpO2All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Less than or equal to 1 month of age
- Weight <3kg
- Subjects admitted with standard of care (SOC) arterial blood sampling line already in place
Key exclusion criteria (4 listed)
- Subjects with underdeveloped skin
- Subjects with abnormalities at the planned application sites that would interfere with system measurements
- Subjects with known allergic reactions to foam/rubber products and adhesive tape
- Deformities of limbs, absence of feet, sever edema, and other at the discretion of the Principal Investigator
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 |
|---|---|---|
| RD SET Neo SpO2All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor. | Device | RD SET Neo SpO2 |
Primary outcome
Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation
Time frame: up to 8 hours
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Evaluation of SpO2 Performance
Not yet recruiting
SpO2 Infant and Pediatric Study
SpO2 (Peripheral Oxygen Saturation) Measurement Validation, SpO2
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?
A study testing RD SET Neo SpO2 in people with Evaluation of SpO2 Performance, run by Masimo Corporation 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 4 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 20 Feb 2020. 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 20 Feb 2020). 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?
Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation (time frame: up to 8 hours). 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 20 Feb 2020.