NCT02944669

ReWalk Personal Device Postmarket Study

Long-Term, Prospective, Non-Interventional Study Monitoring Safety and Training in Patients With Spinal Cord Injuries and Their Trained Companions Recently Initiated With the ReWalk™ Personal Device

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: ReWalk Robotics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to further evaluate the Multi-Tiered Training Program and to further explore the overall safety profile of the ReWalk Personal Device outside of the institutional setting under conditions of routine medical practice.

Detailed description

This study will monitor and further describe the long-term safety of the ReWalk Personal Device for Subjects and their Companions in institutional and non-institutional environments, such as the clinic, home, and community. The study will also evaluate the adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, their Companions, and their Clinical Trainers, monitor and further describe all ReWalk Personal Device malfunctions and screen for potential Unexpected Adverse Events.

Conditions

• Injuries, Spinal Cord

Interventions

Type	Name	Description
DEVICE	ReWalk Personal Device

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2016-10-26
• Last updated: 2017-02-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study