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

NCT07060911 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-07-11

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

Lung monitoring with the Neola device

Lung monitoring with the Neola device

Sponsors & Collaborators

  • Neola Medical Inc

    lead INDUSTRY

Principal Investigators

  • Valerie Chock, M.D., M.S. Epi · Division of Neonatal and Developmental Medicine Stanford University School of Medicine

  • Vineet Bhandari, MD, DM · Department of Pediatrics The Children's Regional Hospital at Cooper

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-12-31
Completion
2027-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07060911 on ClinicalTrials.gov