Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-02 @ 7:19 AM
Study NCT ID:
NCT02944669
Status:
UNKNOWN
Last Update Posted:
2017-02-02
First Post:
2016-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ReWalk Personal Device Postmarket Study
Sponsor:
ReWalk Robotics, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: