N/A
N=20
Rad-67 Repeatability and Reproducibility
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04196907 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67. — 10 ratio of variance
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rad-67 Pulse CO-Oximeter and DCI Mini sensor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67. |
10 | — |
Summary
The primary objective of this clinical investigation is to evaluate the repeatability and reproducibility of using Rad-67 Pulse CO-Oximeter
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04196907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.