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RECRUITING
NCT06772142
EARLY_PHASE1

Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device

Sponsor: Nervonik

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-11-27

Completion Date

2026-02-20

Last Updated

2025-01-13

Healthy Volunteers

No

Interventions

DEVICE

Peripheral Nerve Stimulation

Peripheral Nerve Stimulation

Locations (1)

Hospital Punta Pacifica

Panama City, Provincia de Panamá, Panama