AmputationNCT07915700
Hand Prosthesis Usability and Performance
A study testing Prototype hand prosthesis and Baseline Comparator Device in people with Amputation, run by Össur Iceland ehf at 1 site in United States.
Trial summary
This study asks individuals with upper limb absence to use a new hand prosthesis, and compare it's performance to their own hand prosthesis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Prototype hand prosthesis and Baseline Comparator Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multi-articulating hand experience
- At least 18 years old
- Transradial, acquired amputation or congenital upper limb absence
- Unilateral upper limb absence preferred Good socket comfort in own prosthesis (>/= 6 on Hanspal socket comfort score)
Who cannot join
- Any health conditions that pose a risk to participation in study events (in the opinion of the Investigator), e.g. Visual impairment; Cognitive impairment
- Cognitively unable to provide informed consent or comply with the study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ossur Americas
Dublin, Ohio, 43017
Lynsay Emmrich, +16149278008, lynsay.emmrich@emblamedical.com
About this study
Official title: Validation of a Multi-articulating Hand Prosthesis
This study asks individuals with upper limb absence to use a new hand prosthesis, and compare it's performance to their own hand prosthesis
Read the detailed description
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
- Conditions
- Amputation
- Being tested
- Prototype hand prosthesis, Baseline Comparator Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype hand prosthesisDevice
Prototype hand prosthesis
Baseline Comparator DeviceDevice
All participants will use their own prosthesis
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will use the prototype device Receives: Device: Prototype hand prosthesis; Device: Baseline Comparator Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and each post-treatment visit (x3 visits over 12 weeks)
Secondary outcomes (1)
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.
Measured: At baseline and each post-treatment visit (x3 visits over 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start9 Mar 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynsay Emmrich, Principal investigator, Össur Iceland ehf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915700
- Sponsor's protocol ID
- CIP2022041968
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Multi-articulating Hand Prosthesis
- ClinicalTrials.gov ID
- NCT07915700
- Acronym / sponsor ID
- CIP2022041968
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study asks individuals with upper limb absence to use a new hand prosthesis, and compare it's performance to their own hand prosthesis
Detailed description
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
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: Prototype hand prosthesis, Device: Baseline Comparator DeviceAll participants will use the prototype device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Multi-articulating hand experience
- At least 18 years old
- Transradial, acquired amputation or congenital upper limb absence
- Unilateral upper limb absence preferred Good socket comfort in own prosthesis (>/= 6 on Hanspal socket comfort score)
Key exclusion criteria (2 listed)
- Any health conditions that pose a risk to participation in study events (in the opinion of the Investigator), e.g. Visual impairment; Cognitive impairment
- Cognitively unable to provide informed consent or comply with the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototype hand prosthesisPrototype hand prosthesis | Device | All participants |
| Baseline Comparator DeviceAll participants will use their own prosthesis | Device | All participants |
Primary outcome
Grip Accuracy
Time frame: At baseline and each post-treatment visit (x3 visits over 12 weeks)
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.
1 secondary outcome
Disability of the Arm Shoulder and Hand
Time frame: At baseline and each post-treatment visit (x3 visits over 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lynsay Emmrich principal investigator
Össur Iceland ehf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype hand prosthesis and Baseline Comparator Device in people with Amputation, run by Össur Iceland ehf at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daire McGuinness (01506533178, dmcguinness@ossur.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Accuracy (time frame: At baseline and each post-treatment visit (x3 visits over 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.