Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control (NCT07325708) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control
Australia10 participantsStarted 2026-04-17
Plain-language summary
The CYBORG Study is a first-in-human clinical investigation evaluating the safety and performance of the Phantom X System, an implantable electromyography (EMG) sensor array designed to provide control of upper-limb prostheses. The study will assess surgical feasibility, device function, signal quality, and the system's ability to support intuitive prosthetic control during functional tasks. Participants will undergo implantation of the Phantom X sensors and complete a series of in-clinic visits to assess functional performance of the Phantom X system. Patient-reported outcomes will also be collected at various timepoints.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient has a unilateral upper-limb difference (congenital or acquired) at the transradial or wrist level.
. The patient currently uses a myoelectric prosthesis or is deemed a suitable candidate for fitting with a myoelectric prosthesis.
. Patient is a suitable candidate for the implantation of the Phantom X sensor array as assessed by the implanting physician.
. Patient is at least 18 years old and can provide written informed consent.
. Patient is willing to comply with study protocol and make required study visits.
. Patient received amputation ≥ 12 months prior to consent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of Phantom X system during the implantation procedure, peri-procedurally, and 9 weeks thereafter
Timeframe: 9 weeks
2
Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument
Timeframe: 9 weeks
3
Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument
. Patient has a significant cognitive deficit resulting in inability to follow study directions.
. Patient has a neuro-muscular deficit and is unable to initiate substantial muscle contraction in the residual limb as determined by the implanting physician or investigator.
. Patient has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
. The patient has a planned medical procedure (e.g., surgery) during the study period that could interfere with compliance with study visits or assessments.
. Patient has an allergy to anesthesia or other medication used for sedation in the study.
. Patient has an active implantable device (e.g. cardiac pacemaker, neuromodulation device) that can potentially interfere with the performance of Phantom X system.
. Patient may require an MRI during the study duration.
. Implantation of the device poses a health risk to the patient as determined by the implanting physician.