Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-03 @ 5:08 PM
Study NCT ID:
NCT03622866
Status:
TERMINATED
Last Update Posted:
2021-03-11
First Post:
2018-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Algovita Spinal Cord Stimulation System Hi-Fi Study
Sponsor:
Nuvectra
Organization:
Study Overview
Official Title:
Clinical Trial Comparing Ultra-High Versus Traditional Pulse Widths Using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Persistent or Recurrent Back and/or Leg Pain Following Spinal Surgery
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor bankruptcy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: