Clinical Feasibility of the IMES Transradial Prosthesis
Research type
Research Study
Full title
Clinical Feasibility of the IMES Transradial Prosthesis
IRAS ID
281328
Contact name
Aidan Roche
Contact email
Sponsor organisation
Össur hf
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Össur is a medical device manufacturer and is the Sponsor of the study. Össur is developing a novel control method for upper limb prostheses – the Implantable Myoelectric Sensor System (IMES). \nThe IMES System uses very small (16mm) implanted electrodes which are inserted directly into appropriate muscles. The principle of the IMES system is that by inserting an electrode directly into a residual muscle which is used to perform a certain hand function, an individual may be able to directly control that function in the prosthetic hand. The IMES system is important because it has the potential to provide more intuitive and accurate control to individuals with upper limb absence.\nThe purpose of the study is to investigate the clinical feasibility of the IMES System – worn by study participants as the IMES Transradial Prosthesis. The study is designed to compare IMES control to the current state of the art device, and understand any potential clinical benefits to individuals using the IMES system. \nThree people with upper limb amputation below the elbow will be recruited from NHS Glasgow or NHS Lothian health boards and will take part in the study for approximately 6 months. After screening and informed consent 10-12 sensor implants will be inserted in to optimal muscles in the patient’s residual limb in a minimally invasive surgery. The investigational device (IMES transradial prosthesis) will be custom made to fit them. Patients will be asked their subjective feedback of the device and complete questionnaires regarding e.g. effects on quality of life. Functional tests of speed, accuracy, motion analysis will be carried out. Comparisons will be made to the patient’s own device at baseline. Study procedures will take place at the Sponsor (Ossur) facility and at the participating NHS sites. A multi-disciplinary team will conduct the study - surgeons, psychologists, prosthetists, occupational therapists.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0079
Date of REC Opinion
25 Jun 2021
REC opinion
Favourable Opinion