An interventional study of Prototype hand prosthesis and Baseline Comparator Device in Amputation, sponsored by Össur Iceland ehf. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Össur Iceland ehf (part of Embla Medical hf.) · Not applicable, Interventional, and Device feasibility
This study asks individuals with upper limb absence to use a new hand prosthesis, and compare it's performance to their own hand prosthesis
A multi-articulating hand prosthesis is compared within subject to baseline (own device) in terms of patient reported outcome measures of satisfaction and adoption, and functional performance
Össur Iceland ehf is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will use the prototype device
Device: Prototype hand prosthesis · Device: Baseline Comparator Device
Prototype hand prosthesis
All participants will use their own prosthesis
Grip Accuracy
Functional observer rated test of ability to perform grips. This test assesses the feasibility that the device can be used as a reliable hand prosthesis when operated by the intended use population. An observer rates the successful achievement of the prompted outcome on a 0-3 scale (0= no output, 3= output achieved without error). The four grips (hand open, hand close, thumb rotation to palm, thumb rotation away from palm) are repeated x3, resulting in a minimum summary score of 0 or a maximum summary score of 36.
Time frame: At baseline and each post-treatment visit (x3 visits over 12 weeks)
Disability of the Arm Shoulder and Hand
The Disability of the Arm Shoulder and Hand (DASH) is a patient reported outcome measure assessing perceived personal ability. The questionnaire consists of 30 items which the participant scores on a 1-5 scale to indicate their perceived ability (1= no difficuly, 5=unable). The summary DASH DISABILITY/SYMPTOM SCORE = \[(sum of n responses) - 1\] x 25, where n is equal to the number of completed responses, and a maximum score of 100 can be achieved. A higher score indicates greater perceived disability.
Time frame: At baseline and each post-treatment visit (x3 visits over 12 weeks)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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