Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT05630495
Status:
UNKNOWN
Last Update Posted:
2023-07-14
First Post:
2022-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
Sponsor:
Picterus AS
Organization:
Study Overview
Official Title:
Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:
* Demonstrate that Picterus system performs accurately in Indonesian newborns
* Ensure that Picterus is in line with users' needs in Indonesia
* Demonstrate that Picterus system performs accurately in Indonesian newborns
* Ensure that Picterus is in line with users' needs in Indonesia
Detailed Description:
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:
* Demonstrate that Picterus system performs accurately in Indonesian newborns
* Ensure that Picterus is in line with users' needs in Indonesia
* Demonstrate that Picterus system performs accurately in Indonesian newborns
* Ensure that Picterus is in line with users' needs in Indonesia
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: