NCT07060911

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Neola Medical Inc · Industry
• Sex: All
• Age: 1 Day – 44 Weeks
• Healthy volunteers: Not accepted

Summary

Pivotal 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 during standard NICU procedures on neonates.

Conditions

• RDS of Prematurity
• Preterm Birth
• Lung Diseases

Interventions

Type	Name	Description
DEVICE	Lung monitoring with the Neola device	Lung monitoring with the Neola device

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2025-07-11
• Last updated: 2025-07-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study