AnemiaNCT03610269

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

A study testing INVSENSOR00026 (Pulse CO-Oximeter and sensor) in people with Anemia, run by Masimo Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Anemia
What is being tested?: INVSENSOR00026 (Pulse CO-Oximeter and sensor)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 143 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2018to 16 Aug 2018
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 years of age or older
Subject has given written informed consent to participate in the study

Who cannot join

(*) Pregnant or positive human chorionic gonadotropin (hCG) test
(*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis
(*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)
(*) Subjects who are currently taking anticoagulant medication
(*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic
(*) 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 psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc.

Show all 11Show fewer

(*) 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.
(*) Subjects with elevated blood pressure, skin or wrist abnormalities that may interfere with an arterial blood draw as determined by investigator or research medical staff.
(*) Subjects who intend on participating in heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw
Subjects deemed not suitable for the study at the discretion of the investigator or research medical staff
Note: () May be self-reported by subject

Trial locations and contacts

1 site in 1 country.

United States1 site

Torrance Clinical Research
Lomita, California, 90717

Other trials in United States

About this study

Conditions: Anemia
Being tested: INVSENSOR00026 (Pulse CO-Oximeter and sensor)
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INVSENSOR00026 (Pulse CO-Oximeter and sensor)Device
Noninvasive Pulse CO-Oximeter and sensor that measures noninvasive hemoglobin (SpHb)

Study groups in NCT03610269
Study group	Role	What they receive
INVSENSOR00026	Experimental	All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb). Receives: Device: INVSENSOR00026 (Pulse CO-Oximeter and sensor)

What is being measured

The primary outcome is the main question the study is designed to answer.

Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation
Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, 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 Arms Error value.
Measured: Up to 2 hours per subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201816 Aug 2018

First posted1 Aug 2018
Study start1 Aug 2018
Primary completion16 Aug 2018
Study completion16 Aug 2018

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 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: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03610269
Sponsor's protocol ID: TORR0003
Status last verified: Jun 2019
First submitted: 26 Jul 2018
Last updated: 25 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026
ClinicalTrials.gov ID: NCT03610269
Acronym / sponsor ID: TORR0003
Conditions: Anemia
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 1 Aug 2018 (actual)
Primary completion: 16 Aug 2018 (actual)
Study completion: 16 Aug 2018 (actual)
First posted: 1 Aug 2018 (actual)
Results: Posted 25 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
INVSENSOR00026	Experimental	Device: INVSENSOR00026 (Pulse CO-Oximeter and sensor)All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

18 years of age or older
Subject has given written informed consent to participate in the study

Key exclusion criteria (11 listed)

(*) Pregnant or positive human chorionic gonadotropin (hCG) test
(*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis
(*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)
(*) Subjects who are currently taking anticoagulant medication
(*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic

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
INVSENSOR00026 (Pulse CO-Oximeter and sensor)Noninvasive Pulse CO-Oximeter and sensor that measures noninvasive hemoglobin (SpHb)	Device	INVSENSOR00026

Primary outcome

Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation
Time frame: Up to 2 hours per subject
Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, 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 Arms Error value.

Results and safety

Results posted to the registry on 25 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
INVSENSOR00026	143	127

Primary outcome: Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation

Time frame: Up to 2 hours per subject. Number. Unit: g/dL

Measure	INVSENSOR00026 n = 111
Value	0.93

Adverse events

Time frame: During the duration of the study and 2 weeks after participation in the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INVSENSOR00026	0 of 127 (0%)	2 of 127 (1.6%)	0 of 127

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
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RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
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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?

A study testing INVSENSOR00026 (Pulse CO-Oximeter and sensor) in people with Anemia, 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 2 inclusion and 11 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 25 Jun 2019. 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 25 Jun 2019). 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 Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation (time frame: Up to 2 hours per subject). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03610269.

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 25 Jun 2019.