Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-02-28 @ 11:41 PM
Study NCT ID:
NCT02221934
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-06
First Post:
2014-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Electrical Nerve Block for Amputation Pain
Sponsor:
Neuros Medical, Inc.
Organization:
Study Overview
Official Title:
High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
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:
The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
Detailed Description:
The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| QUEST Trial | OTHER | Neuros Medical | View |