Prospective Study to Validate the Clinical Accuracy of th... | NCT05685654

Studies
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation

NCT05685654

Sponsor

Norbert Health

Status

Unknown status

Last Update Posted

Jan 23, 2023Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Healthy
Hypoxia

Interventions

Norbert Device

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2023Estimated

Primary Completion Date

Mar 2023Estimated

Completion Date

Mar 2023Estimated

First Submitted Date

Jan 5, 2023

First Submission Date that Met QC Criteria

Jan 12, 2023

First Posted Date

Jan 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2023

Last Update Posted Date

Jan 23, 2023Actual

Name	Class
Duke University	OTHER

Description Module

Brief Summary

The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2 validation.

Detailed Description

The study is a single center, prospective, non-randomized study to measure the accuracy of an investigational device compared to blood reference values. The design of the study will be conducted in accordance with the recommendations of ISO 80601-2-61:2011 Annex EE.2 Procedure for invasive laboratory testing on healthy volunteers. The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the Norbert Device. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3.5 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Name	Type	Description	Arm Group Labels	Other Names
Norbert Device	Device	The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SpO2 root mean square accuracy of the Norbert Device	SpO2 root mean square accuracy will be calculated following FDA guidelines.	Up to 1 hour
SpO2 bias of the Norbert Device	SpO2 bias calculation of the Norbert Device will follow the FDA guidelines for analyzing population mean bias, between-subject variance, and within-subject variance.	Up to 1 hour
Bland-Altman plots with linear regression line and 95% upper and lower limits of agreement	A method comparison study will be analyzed with a Bland-Altman plot. This study will produce limits of agreement (LoA) and associated confidence intervals from the two measurements obtained on each subject. The conclusion that the two measurements are in agreement depends on whether the confidence intervals constructed from the data are within the boundaries set from the maximum allowable difference.	Up to 1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy, male or female subjects between the ages of 18 to 50 years
Completion of a health screening for a medical history by a licensed physician, nurse practitioner, or physician assistant
Previously measured hemoglobin electrophoresis with normal result recorded in Duke Epic EHR
Minimum weight 40kg; BMI within range 18.0 - 35.0
Assigned American Society of Anesthesiologists (ASA) Physical Status 1 by Principal Investigator or delegate

Exclusion Criteria:

Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
Prior known severe allergies to medical grade adhesive/tape (Band-Aid)
Taking any medication other than birth control
Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational interventional drug, device, or biologic study
Has a negative Allen's Test to confirm non patency of the collateral artery
Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure
Is female with a positive urine pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breast feeding
Has anemia
Has heparin allergy
Has a history of sickle cell trait or thalassemia [self-reported]
Has a positive urine cotinine test or urine drug screen or oral ethanol test
Has a room air saturation less than 95% by pulse oximetry
Has a clinically significant abnormal EKG
Has a COHb greater than 3%, or MetHb greater than 2%
Students and Employees under the direct supervision of PI or Sub-I

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Up to 15 healthy, adult volunteers, aged 18 - 50, will be enrolled. The subjects will be distributed across both genders as equally as practical and with a range of skin pigmentation.

Sampling Method

Non-Probability Sample

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms