allphones: Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones

Sponsor

Picterus AS (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05955144

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Jaundice	Device: Picterus JP	N/A

Detailed Description

The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.

Picterus JP bilirubin estimates from a Samsung S7 will be compared with three smartphones with different camera types and a TcB measurement The clinical outcomes will be compared to our camera validation systems. Skin color measurements using a spectrophotometer will be used for technical optimization of the camera validation system

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Clinical Validation of the Screening Tool Picterus Jaundice Pro to Assess Neonatal Jaundice Using Different Types of Smartphones

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Repeatable bilirubin measurement independent of phone all subjects will receive bilirubin measurement from 4 different smartphones and a transcutaneous device to ensure that the measurement of bilirubin is not affected by phone camera	Device: Picterus JP Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is placed.

Arm

Intervention/Treatment

Other: Repeatable bilirubin measurement independent of phone

all subjects will receive bilirubin measurement from 4 different smartphones and a transcutaneous device to ensure that the measurement of bilirubin is not affected by phone camera

Device: Picterus JP

Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is placed.

Outcome Measures

Primary Outcome Measures

jaundice screening [6 months]
reproducible jaundice screening independent of smartphone used

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 14 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Infants born with gestational age > 37 weeks.
Birth weight ≥ 2500 grams
Age 1 - 14 days

Exclusion Criteria:

Infants showing signs of inborn disease.
Infants with skin rash or other skin disease that affects the skin where measurements are performed.
Infants transferred to the pediatric ward for medical treatment.
Infants that have received phototherapy in the last 24 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Olav Hospital	Trondheim		Norway	7006

Sponsors and Collaborators

Picterus AS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Picterus AS

ClinicalTrials.gov Identifier:

NCT05955144

Other Study ID Numbers:

allphone

First Posted:

Jul 21, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Jaundice, Neonatal

Jaundice

Study Results

No Results Posted as of Jul 21, 2023