Clinical trial · Interventional
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
NCT02930850CI-TRIAL-00037987completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Healthy | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rad-67 Pulse oximeter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Test subjects
- description
- All subjects are enrolled and receive Rad-67 Pulse oximeter sensor for measurement of hemoglobin.
- interventionNames
- Device: Rad-67 Pulse oximeter
Primary outcomes (1)
- measure
- Accuracy of hemoglobin measurement
- timeFrame
- Up to 2 hours per subject
- description
- Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
Show eligibility criteria text
Inclusion Criteria: * Age: Greater than one month * Weight: Greater than or equal to 3kg * The subject or the subject's legally authorized representative has given written informed consent/assent 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, 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. * Decision-impaired adult and pediatric subjects who are unable to give consent and assent
References
Publications (0)
Data not yet available
No reference posted for this study.