Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT06832306
Status:
RECRUITING
Last Update Posted:
2025-10-22
First Post:
2025-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
STimulation to Activate RespIration
Sponsor:
Lungpacer Medical Inc.
Organization:
Study Overview
Official Title:
A Clinical Study Evaluating Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients With Acute Hypoxemic Respiratory Failure
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
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:
STARI
Brief Summary:
Multi-center, randomized, controlled, open-label Phase 2 feasibility trial. Subjects on mechanical ventilation (MV) for acute hypoxemic respiratory failure (AHRF) with lung injury (including subjects who meet criteria for acute respiratory distress syndrome (ARDS)) will be randomized 2:1 to diaphragm neurostimulation-assisted ventilation (DNAV) using the AeroNova System plus lung-protective ventilation (Treatment) vs. lung-protective ventilation alone (Control).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 75A0123C00021 | OTHER_GRANT | Biomedical Advanced Research and Development Authority (BARDA) | View |