AnemiaNCT03128853
Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility
A study testing Rad-67 and DCI Mini Sensor in people with Anemia and Healthy, run by Masimo Corporation at 2 sites in United States.
Trial summary
Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor. Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- What is being tested?
- Rad-67 and DCI Mini Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2016to 15 Nov 2016
- 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 1 month and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age one month and older
- Weight greater than or equal to 3 kg
- The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
Who cannot join
- Decision-impaired adult and pediatric patients who are unable to give informed consent/assent
- Decision-impaired adult on behalf of a pediatric patient who is unable to assent
- Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
- Subjects deemed not suitable for the study at the discretion of the investigator
- Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site 1
Charlotte, North Carolina
Masimo Clinical Laboratory
Irvine, California, 92618
About this study
Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.
Read the detailed description
This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.
- Being tested
- Rad-67 and DCI Mini Sensor
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rad-67 and DCI Mini SensorDevice
| Study group | Role | What they receive |
|---|---|---|
| Test subjects | Experimental | Each subject receives the Rad-67 and DCI Mini sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference. Receives: Device: Rad-67 and DCI Mini Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability and reproducibility of CO-oximeter and sensor
The Repeatability and Reproducibility of the sensor will be assessed by varying the testing conditions (operator/device, finger, subject, and repetition) to determine the device and sensor's precision in SpHb measurements.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start31 Oct 2016
- Primary completion15 Nov 2016
- Study completion15 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- 57 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
- NCT03128853
- Sponsor's protocol ID
- TP-18216
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2017
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility
- ClinicalTrials.gov ID
- NCT03128853
- Acronym / sponsor ID
- TP-18216
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 15 Nov 2016 (actual)
- First posted
- 25 Apr 2017 (actual)
- 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.
Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.
Detailed description
This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test subjects | Experimental | Device: Rad-67 and DCI Mini SensorEach subject receives the Rad-67 and DCI Mini sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference. |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age one month and older
- Weight greater than or equal to 3 kg
- The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
Key exclusion criteria (5 listed)
- Decision-impaired adult and pediatric patients who are unable to give informed consent/assent
- Decision-impaired adult on behalf of a pediatric patient who is unable to assent
- Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
- Subjects deemed not suitable for the study at the discretion of the investigator
- Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, 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 |
|---|---|---|
| Rad-67 and DCI Mini Sensor | Device | Test subjects |
Primary outcome
Repeatability and reproducibility of CO-oximeter and sensor
Time frame: 120 minutes
The Repeatability and Reproducibility of the sensor will be assessed by varying the testing conditions (operator/device, finger, subject, and repetition) to determine the device and sensor's precision in SpHb measurements.
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 27 Apr 2020.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rad-67 and DCI Mini Sensor in people with Anemia and Healthy, run by Masimo Corporation at 2 sites 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 5 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 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Repeatability and reproducibility of CO-oximeter and sensor (time frame: 120 minutes). 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 27 Apr 2020.