Noninvasive Hemoglobin Repeatability and Reproducibility in a Blood Donation Setting

NCT04490863 | Completed Results FDA Device

• 1 other identifier: SDBB0005
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical investigation is to report on the repeatability and reproducibility of SpHb measurements from Rad-67 devices and DCI Mini sensors used to screen prospective blood donors at a donation center.

Conditions

Healthy; Anemia

Outcome Measures

Primary Outcomes (1)

• Coefficient of Variation of Rad-67

  Coefficient of variation will be computed using Repeatability and Reproducibility variance.

  Approximately 90 minutes per subject

Study Arms (1)

Test subjects

EXPERIMENTAL

All subjects are enrolled and receive Rad-67 Pulse oximeter \& DCI Mini sensor for measurement of hemoglobin.

Device: Rad-67 Pulse oximeter & DCI Mini sensor

Interventions

Rad-67 Pulse oximeter & DCI Mini sensor DEVICE

Noninvasive pulse oximeter that measures hemoglobin

Test subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Blood Bank - Site 1

San Diego, California, 92102, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Vikram Ramakanth
• Organization: Masimo Corporation

ClinicalResearchDept@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 29, 2020
• Study Start: July 16, 2020
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2020
• Last Updated: August 31, 2021
• Results First Posted: August 31, 2021

Record last verified: 2021-08

Locations

US (1)