Noninvasive Hemoglobin Testing, Prospective Blood Donors

NCT04450381 | Completed Results FDA Device

• 1 other identifier: SDBB0004
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Anemia

Outcome Measures

Primary Outcomes (2)

• Rad-67 Sensitivity

  Sensitivity of the the Rad-67 will be determined for its use in a blood donation center

  Up to one hour per subject

• Rad-67 Specificity

  Specificity of the the Rad-67 will be determined for its use in a blood donation center

  Up to one hour 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 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.

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

clincalresearchdept@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: June 25, 2020
• First Posted: June 29, 2020
• Study Start: June 23, 2020
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: July 27, 2021
• Results First Posted: July 27, 2021

Record last verified: 2021-07

Locations

US (1)