STIMIT Activator 1 IDE Study

Conditions

• Diaphragm Issues

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jan 24, 2024

Status verified

Nov 2025

Primary completion

Apr 30, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Stimulation Group
  The intervention group will receive non-invasive stimulation of the phrenic nerve for activation of the diaphragm.
• No Intervention: Control Group
  The control group will not received intervention and will be treated with standard of care.

Primary Outcome Measure

Efffectiveness: Preservation of Diaphragm Thickness [ Time Frame: Up to Day 10 ]

Central Contacts

• Tsiry Rabemahefa
  218-329-7356
  [email protected]

Locations (3)

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