NCT05955144

Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Picterus AS · Industry
• Sex: All
• Age: 1 Day – 14 Days
• Healthy volunteers: Accepted

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.

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

Conditions

• Neonatal Jaundice

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-12-31
• Completion: 2024-12-01
• First posted: 2023-07-21
• Last updated: 2023-07-21

Locations

1 site across 1 country: Norway