Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhantom Neuro Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control
DeviceParticipants receive the Phantom X implantable EMG sensor array and telemetry module to enable myoelectric control of an upper-limb prosthesis.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Phantom XExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of Phantom X system during the implantation procedure, peri-procedurally, and 9 weeks thereafter
Safety is characterized by collecting device and procedure related adverse events during device implantation and 9-week study follow-up.
Time frame
9 weeks2
Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument
Average and standard deviation of ACMC scores will be computed for all participants
Time frame
9 weeks3
Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument
Average and standard deviation of tBBT scores will be computed for all participants
Time frame
9 weeksSecondary outcomes
1
Safety of Phantom X system during the implantation procedure, peri-procedurally, and 21 weeks thereafter
Safety is characterized by collecting device and procedure related adverse events during device implantation and 21-week study follow-up.
Time frame
21 weeks2
Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument
Average and standard deviation of ACMC scores will be computed for all participants
Time frame
21 weeks3
Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument
Average and standard deviation of tBBT scores will be computed for all participants
Time frame
21 weeks4
Phantom X Signal-to-Noise Ratio (SNR)
Characterize signal-to-noise ratio (SNR) of electromyography (EMG) signals obtained using Phantom X system. Average and standard deviation of SNR for all participants will be computed
Time frame
9 weeks and 21 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Phantom Neuro Inc.
Lead sponsor
Cabrini Health, Melbourne, Australia
Collaborator
ProMotion Prosthetics, Moorabbin, Australia
Collaborator
Source ClinicalTrials.gov