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Recruiting NCT04936789

Clinical Feasibility of the IMES Transradial Prosthesis

Trial Parameters

Condition Amputation
Sponsor Össur Iceland ehf
Study Type INTERVENTIONAL
Phase N/A
Enrollment 3
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2023-01-01
Completion 2026-01
Interventions
IMES

Brief Summary

This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis

Eligibility Criteria

Inclusion Criteria: * (unilateral acquired transradial) amputation * residual limb size requirements to fit investigational device componentry * at least 6 residual muscle locations available for implantation * good compliance with health service (rehabilitation) * willing to undergo surgical implantation of IMES Sensor implants * experience with myoelectric upper limb prostheses * using own myoelectric device approximately 6-8h/day * able to provide informed consent and attend the study visits Exclusion Criteria: * any condition which in the opinion of the investigator poses a risk to health * neurological disorder that may prohibit accurate control * major injury proximal to the level of amputation * neuromuscular disorder * nerve transection or palsy that may cause de-innervation of muscles planned for implantation * allergy to implanted materials * existing active implant

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