AmputationNCT04936789
Clinical Feasibility of the IMES Transradial Prosthesis
A study testing IMES in people with Amputation, run by Össur Iceland ehf at 1 site in United Kingdom.
Trial summary
This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputation
- What is being tested?
- IMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2023to Jan 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Greater Glasgow and Clyde
Glasgow, Glasgow, 0000 000
Aidan Roche
About this study
This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis
Read the detailed description
The study assesses the feasibility of an implantable myoelectric prosthesis control system to control a transradial prosthesis. Implantable Myoelectric Sensors (IMES) will be implanted into the residual forearm muscles of three transradial amputee subjects. These devices wirelessly transmit electrical muscle signals to an electromechanical prosthetic wrist and hand.
Following a two-week recovery from implantation of up to 16 IMES into residual forearm muscles, subjects will begin a two week training phase. When they receive their custom-fit IMES Transradial Prosthesis (including electromechanical wrist and hand) subjects initiate approximately four months of home use. Subjects will be offered up to five post-study follow-up visits. The usability and functionality of the prosthetic system will be evaluated throughout the study.
- Conditions
- Amputation
- Being tested
- IMES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMESDevice
Surgical implantation of IMES
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Single arm. All subjects will receive the intervention. Comparator device will be subjects' own prosthesis at baseline. Receives: Device: IMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Accuracy
Self-drafted assessment of accuracy in prosthesis movements. The purpose of this measure is to quantify subjects' ability to use the investigational device to control specific prosthetic movements. When performing the Accuracy Test, the subject attempts to execute a series of specified wrist and hand movements using the investigational device. An objective rater scores each movement on a 0-3 scale with 0 = no movement observed and and 3 = movement observed (with no unintended movements). A score is given for each movement and a combined score is derived from the complete set of movements.
Administered as a repeated measure, the Grip Accuracy test assesses Change over time (training effect).
Measured: The measure will be carried out 11 times during the study, at Baseline with the subject's own device for comparison, and at 10 study visits with the investigational device conducted over approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Jan 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 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
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aidan Roche, MD, Principal investigator, NHS; University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936789
- Sponsor's protocol ID
- CIP2020072116
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of the IMES Transradial Prosthesis
- ClinicalTrials.gov ID
- NCT04936789
- Acronym / sponsor ID
- CIP2020072116
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 Jun 2021 (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 will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis
Detailed description
The study assesses the feasibility of an implantable myoelectric prosthesis control system to control a transradial prosthesis. Implantable Myoelectric Sensors (IMES) will be implanted into the residual forearm muscles of three transradial amputee subjects. These devices wirelessly transmit electrical muscle signals to an electromechanical prosthetic wrist and hand.
Following a two-week recovery from implantation of up to 16 IMES into residual forearm muscles, subjects will begin a two week training phase. When they receive their custom-fit IMES Transradial Prosthesis (including electromechanical wrist and hand) subjects initiate approximately four months of home use. Subjects will be offered up to five post-study follow-up visits. The usability and functionality of the prosthetic system will be evaluated throughout the study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: IMESSingle arm. All subjects will receive the intervention. Comparator device will be subjects' own prosthesis at baseline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| IMESSurgical implantation of IMES | Device | Single arm |
Primary outcome
Grip Accuracy
Time frame: The measure will be carried out 11 times during the study, at Baseline with the subject's own device for comparison, and at 10 study visits with the investigational device conducted over approximately 6 months.
Self-drafted assessment of accuracy in prosthesis movements. The purpose of this measure is to quantify subjects' ability to use the investigational device to control specific prosthetic movements. When performing the Accuracy Test, the subject attempts to execute a series of specified wrist and hand movements using the investigational device. An objective rater scores each movement on a 0-3 scale with 0 = no movement observed and and 3 = movement observed (with no unintended movements). A score is given for each movement and a combined score is derived from the complete set of movements. Administered as a repeated measure, the Grip Accuracy test assesses Change over time (training effect).
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 21 Oct 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.
Aidan Roche, MD principal investigator
NHS; University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMES in people with Amputation, run by Össur Iceland ehf at 1 site in United Kingdom.
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 8 inclusion and 7 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 21 Oct 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 Kingdom. 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, BSc (00441315070097, 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: The measure will be carried out 11 times during the study, at Baseline with the subject's own device for comparison, and at 10 study visits with the investigational device conducted over approximately 6 months.). 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 21 Oct 2026.