NCT06772142

Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nervonik · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, 30 patient prospective single arm evaluation of the Nervonik system in symptomatic patients with chronic severe knee, elbow or shoulder pain. COHORT 1: The initial cohort of patients will receive the Nervonik neurostimulator for up to 8 hours. The patient will remain local to the care facility for implant stimulator program changes until the patient is satisfied with the degree of pain relief. The implant will be removed from the patient at the end of the evaluation. COHORT 2: The second cohort of patients will include those patients from cohort 1 who have determined the Nervonik implant provides suitable pain relief and agree to have a permanent implant placed. In addition, the second cohort includes non-cohort one patients meeting the trial requirements and agreeing to participate in the trial.

Conditions

• Peripheral Nerve Disorder

Interventions

Type	Name	Description
DEVICE	Peripheral Nerve Stimulation	Peripheral Nerve Stimulation

Timeline

• Start date: 2024-11-27
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-01-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Panama