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
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