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Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

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Masimo

Status

Completed

Conditions

Anemia

Treatments

Device: INVSENSOR00026 (Pulse CO-Oximeter and sensor)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03610269
TORR0003

Details and patient eligibility

About

The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).

Enrollment

143 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18 years of age or older
  • Subject has given written informed consent to participate in the study

Exclusion criteria

  • (*) Pregnant or positive human chorionic gonadotropin (hCG) test
  • (*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis
  • (*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)
  • (*) Subjects who are currently taking anticoagulant medication
  • (*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic
  • (*) 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 psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc.
  • (*) 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.
  • (*) Subjects with elevated blood pressure, skin or wrist abnormalities that may interfere with an arterial blood draw as determined by investigator or research medical staff.
  • (*) Subjects who intend on participating in heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw
  • Subjects deemed not suitable for the study at the discretion of the investigator or research medical staff

Note: (*) May be self-reported by subject

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

143 participants in 1 patient group

INVSENSOR00026
Experimental group
Description:
All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
Treatment:
Device: INVSENSOR00026 (Pulse CO-Oximeter and sensor)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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