NCT06917326

Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates

Clinical Pilot Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Neola Medical AB · Industry
• Sex: All
• Age: 1 Day – 14 Days
• Healthy volunteers: Not accepted

Summary

Clinical pilot study to assess safety and performance of Neola®, a novel lung monitoring device for neonates

Detailed description

The purpose of the study is to demonstrate that the device is safe and performs as intended under anticipated use conditions. The performance of Neola will be evaluated in terms of ability to continuously measure and display the relative lung volume and absolute oxygen gas concentration on neonates. The results of this clinical investigation will provide further information for the design of a subsequent full-scale clinical investigation.

Conditions

• RDS of Prematurity
• Preterm Birth
• Lung Diseases

Interventions

Type	Name	Description
DEVICE	Monitoring	Lung monitoring with the Neola device

Timeline

• Start date: 2025-05-20
• Primary completion: 2026-03-12
• Completion: 2026-03-12
• First posted: 2025-04-08
• Last updated: 2026-03-18

Locations

1 site across 1 country: Sweden