NCT02221934

Electrical Nerve Block for Amputation Pain

High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Neuros Medical, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-Amputation Pain
• Phantom Limb Pain
• Residual Limb Pain
• Stump Pain

Interventions

Type	Name	Description
DEVICE	Altius	Electrical signal

Timeline

• Start date: 2014-10-09
• Primary completion: 2021-12-31
• Completion: 2025-09-01
• First posted: 2014-08-21
• Last updated: 2025-06-06
• Results posted: 2023-09-11

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated device study