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NCT06058910
Bilistick Point-of-care System 2.0 Bilirubin Validation
trial testing Bilistick System 2.0 point-of-care testing device in Neonatal Screening in 80 participants. Completed in 9 September 2024.
16 June 2024
Quick facts
| Lead sponsor | Kettering Health Network |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 1 February 2024 |
| Primary completion | 16 June 2024 |
| Estimated completion | 9 September 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Bilistick System 2.0 point-of-care testing device
Conditions studied
- Neonatal Screening — all drugs for Neonatal Screening →
- Kernicterus — all drugs for Kernicterus →
- Newborn Jaundice — all drugs for Newborn Jaundice →
- Point-of-Care Testing — all drugs for Point-of-Care Testing →
Sponsor
Kettering Health Network
Who can join
Under 2 Weeks, any sex, with Neonatal Screening or Kernicterus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected for both a diagnostic reference device and Bilistick System 2.0 point-of-care device. Whole blood samples collected from male or female newborns (\<2-weeks of age) born at a Kettering Health Network facility to obtain a total of 80 valid comparison pairs between the reference device and the Bilistick System 2.0 point-of-care device with current laboratory standards.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06058910
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neonatal Screening
Currently open trials in the same condition.
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Other Kettering Health Network trials
Trials by the same sponsor.
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- NCT03867539 — Exparel and Education to Avoid Opioids After Carpal Tunnel Release · Phase 4 · recruiting
- NCT03995641 — The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation · Phase 4 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06058910 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kettering Health Network
- Last refreshed: 13 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06058910.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing