CompletedNot Applicable

Noninvasive Hemoglobin Testing, Prospective Blood Donors

United States131 participantsStarted 2020-06-23

Plain-language summary

The objective of this clinical investigation is to evaluate the pulse oximeter devices for screening prospective blood donors. The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer in a blood donation setting.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least 18 years of age * Weight at least 110 pounds * Subjects with the intention of being screened for eligibility to donate blood * The subject has given written informed consent to participate in the study Exclusion Criteria: * 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, infections, abnormalities, etc. * Subjects unwilling and/or unable to remove nail polish or acrylic nails * Subjects with blood cancers such as leukemia * Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia * Subjects with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc. * Subjects with self-disclosed/known pregnancy at the time of enrollment * Subjects deemed not suitable for the study at the discretion of the investigator * Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rad-67 Sensitivity

Timeframe: Up to one hour per subject

Rad-67 Specificity

Timeframe: Up to one hour per subject

Trial details

NCT IDNCT04450381

SponsorMasimo Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-07

Results submitted2021-07-06

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