Artix Validation Study
Research type
Research Study
Full title
Artix Validation Study
IRAS ID
337192
Contact name
Thor Fridriksson
Contact email
Sponsor organisation
Össur Iceland hf
Duration of Study in the UK
0 years, 5 months, 4 days
Research summary
The objective of the study is to test the new prosthetic hand (Artix) and powered wrist rotator (PWR) from the manufacturer Ossur (the Sponsor of the study), before they are launched on the market, to make sure they perform as expected when used by individuals with upper limb absence (the intended patient population). Ossur make the i-limb hand which has been on the market for several years. We will invite four people who already use the i-Limb hand and ask them to complete some baseline tests before providing them with the ARtix hand (used with the PWR, depending on participant presentation and preference), so that we can compare the two hands. We want to make sure the Artix (+PWR where relevant) is satisfactory to the prosthesis users, and performs as well as the i-Limb. The participants will be asked to use the Artix (+PWR) at home for 4 weeks to be able to properly evaluate the Artix (+PWR), followed by more functional tests to complete the study. The participants will return the investigational devices at the end of the study. Ossur will evaluate the results to confirm that the investigational devices are safe and effective beforethey are offered for sale.
REC name
South East Scotland REC 02
REC reference
24/SS/0081
Date of REC Opinion
6 Nov 2024
REC opinion
Further Information Favourable Opinion