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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COHORT 1, Acute | Other | 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, Chronic | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral Nerve Stimulation | Device | Peripheral Nerve Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint 1 | Safety - reporting of adverse events | Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2] |
| Primary Endpoint 2 | Device performance - successfully delivering current to the nerve | Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2] |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome 1 | Average pain intensity, Long Term durability of Average Pain Intensity (Numeric Rating Scale (NRS) | Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2] |
| Secondary Outcome 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Depatment Chairman, Neurology | Contact | 5072048000 | dr.ricardo.bermudez@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Punta Pacifica | Recruiting | Panama City | Provincia de Panamá | 0831-01593 | Panama |
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| ID | Term |
|---|---|
| D009443 | Neuritis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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Patient Global Impression of Change (PGIC) - PGIC assesses the patient's impression of change in quality of life.
| Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2] |
| Secondary Outcome 3 | Patient Interview | Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2] |