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OpenTrials
Completed

NCT Number: NCT04196907

Rad-67 Repeatability and Reproducibility

The primary objective of this clinical investigation is to evaluate the repeatability and reproducibility of using Rad-67 Pulse CO-Oximeter

Completed

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

San Diego Blood Bank

San Diego, California, 92102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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 or 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
  • 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.

Treatment and study plan

Rad-67 Pulse CO-Oximeter and DCI Mini sensor

Device

Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin.

Primary outcomes

  1. Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67.

    Time frame: 1 hour

    Quality of hemoglobin measurements is defined as a variance ratio of total Gage repeatability and reproducibility variance to total variance. Subject, operator and device were considered as components to calculate this ratio.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Official study title

Noninvasive Hemoglobin Spot Check Repeatability and Reproducibility in a Blood Donation Setting

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2019
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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