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A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System

NCT07477054 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-17

No results posted yet for this study

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

  • Ventilator Induced Diaphragm Dysfunction

Interventions

DEVICE

Lungpacer Diaphragm Pacing Therapy

Transvenous phrenic nerve stimulation to induce diaphragm contraction.

Sponsors & Collaborators

  • Lungpacer Medical Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-02-01
Completion
2028-02-01
FDA Device
Yes

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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 NCT07477054 on ClinicalTrials.gov