NCT06897280

Clinical Trial of MED HF10™ Spinal Cord Stimulation for the Treatment of Chronic Pain

A Single-Center, Prospective Clinical Trial of MED HF10™ Spinal Cord Stimulation for the Treatment of Chronic Pain

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Nevro Corp · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, prospective, non-randomized exploratory study in subjects with chronic, intractable back pain and/or leg pain per the center's routine practice. The primary endpoint is the distribution of responders by 'lowest preferred pulse dose (PD)' setting, where a subject is a responder to the lowest PD setting they preferred prior to entering the Observational period. The study is performed in patients who already have Nevro SCS devices implanted.

Conditions

• Chronic, Intractable Back Pain And/or Leg Pain

Interventions

Type	Name	Description
DEVICE	SCS Device Program Setting	A Pulse Dose setting specifies a brief duration of stimulation 'on' and stimulation 'off' durations, applied in a continuously cycled manner

Timeline

• Start date: 2021-11-16
• Primary completion: 2024-11-16
• Completion: 2026-12-01
• First posted: 2025-03-26
• Last updated: 2025-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study