Trials / Not Yet Recruiting
Not Yet RecruitingNCT07477054
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System - The AERO-PAS Study
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Lungpacer Medical Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A single-arm, prospective, multicenter cohort study to assess the 30-day continued safety and effectiveness of the AeroPace System in patients on mechanical ventilation (MV) at least 96 hours and who have not weaned. This is a study collecting real-world data in a post-market setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lungpacer Diaphragm Pacing Therapy | Transvenous phrenic nerve stimulation to induce diaphragm contraction. |
Timeline
- Start date
- 2026-07-01
- Primary completion
- 2028-02-01
- Completion
- 2028-02-01
- First posted
- 2026-03-17
- Last updated
- 2026-03-17
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07477054. Inclusion in this directory is not an endorsement.