Post-market surveillance of NeuRx Diaphragm Pacing System for patients with spinal cord injury (cervical) and central hypoventilation syndrome dependent on mechanical ventilation that allow diaphragmatic contraction by electrical stimulation of the phrenic nerve

Post-market surveillance of NeuRx Diaphragm Pacing System for patients with spinal cord injury (cervical) and central hypoventilation syndrome dependent on mechanical ventilation that allow diaphragmatic contraction by electrical stimulation of the phrenic nerve - Post-market surveillance of NeuRx Diaphragm Pacing System

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043143

Enrollment

Registered

2021-01-27

Start date

2019-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The patients with spinal cord injury (cervical) and central hypoventilation syndrome dependent on mechanical ventilation that allow diaphragmatic contraction by electrical stimulation of the phrenic nerve

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who were registered in the post market surveillance of NeuRx Diaphragm Pacing System

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
<Safety> Occurrence rate of adverse events and malfunctions of the device <Efficacy> 1) Tidal volume acquired by using NeuRx 2) Continuous use time and long-term use of NeuRx	—

Secondary

Measure	Time frame
<Efficacy> 1) Maintaining or improving diaphragmatic function 2) Maintaining oxygen saturation by using NeuRx 3) Improved QOL by using NeuRx	—

Countries

Japan

Contacts

Public ContactYuki Kuwabara

USCI Japan, Ltd. Business Planning and Development Department

yuki_kuwabara@usci.co.jp03-6823-1100

Outcome results