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NCT04936789
Clinical Feasibility of the IMES Transradial Prosthesis
Conditions: Amputation
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 3
Sponsor: Össur Iceland ehf
Location: NHS Greater Glasgow and Clyde Glasgow Glasgow
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
Source: ClinicalTrials.gov (NCT04936789). StuddyBuddy aggregates publicly available trial information.