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STIMIT Activator 1 IDE Study

NCT05883163 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-14

No results posted yet for this study

Summary

The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been mechanically ventilated for up to 7 days and are predicted to require additional minimum 48 hours of mechanical ventilation or longer.

Conditions

  • Diaphragm Issues

Interventions

DEVICE

Stimit Activator 1

The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.

Sponsors & Collaborators

  • Stimit AG

    lead INDUSTRY

Principal Investigators

  • Laurent Brochard, MD · St Michael's Hospital Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-24
Primary Completion
2026-04-30
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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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 NCT05883163 on ClinicalTrials.gov