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RecruitingNCT05955144allphonesUpdated Jul 21, 2023

Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones

An interventional study of Picterus JP in Neonatal Jaundice, sponsored by Picterus AS. Recruiting at 1 site in Norway. Open to participants aged 1 Day to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-21.

Sponsored by Picterus AS · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Registered 9 months after the study started (first participant enrolled Oct 2022, registered Jul 2023).
  • Started Oct 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
1 Day to 14 Days
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Neonatal Jaundice

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03

In context

Jaundice, Neonatal

110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.

This study's planned enrollment of 100 is below the median of 150 across 78 interventional studies indexed under Jaundice, Neonatal.

Browse Jaundice, Neonatal studies →

Lead sponsor

Picterus AS is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 14 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • DevicePicterus 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.

06

What researchers measure

Primary outcomes

  1. jaundice screening

    reproducible jaundice screening independent of smartphone used

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05955144
Lead sponsor
Picterus AS
Responsible party
Sponsor
First posted
Jul 21, 2023
Start date
Oct 1, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Jul 21, 2023

Study contacts

Deborah Hill
Contact
deborah@picterus.com
45188628

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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