The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.
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Change in Pain Level as measured by SF-36
Timeframe: Baseline and monthly for up to 7 years postoperatively
Change in Pain Level as measured by LANSS survey
Timeframe: Baseline and monthly for up to 7 years postoperatively
Change in Pain Level as measured by Phantom Limb Questionnaire
Timeframe: Baseline and monthly for up to 7 years postoperatively
RPNI tissue degeneration measured by pain scores
Timeframe: Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.
RPNI electrode migration assessed by changes recording in efficacy and ultrasound
Timeframe: Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.