BridgeMD
New treatment option for Upper Limb Amputation Below Elbow (Injury)
Official title Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control
ClinicalTrials.gov ID: NCT07325708
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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 patient has a planned medical procedure (e.g., surgery) during the study period that could interfere with compliance with study visits or...
- 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...
See the full eligibility 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.
- 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...
- 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.
- Women who are breastfeeding, currently pregnant or planning to become pregnant during the duration of the study or have a positive urine pregnancy test at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Malvern, Victoria, Australia
- Moorabbin, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Malvern, Victoria, Australia; Moorabbin, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.