An interventional study of Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control in Upper Limb Amputation Below Elbow (Injury), Wrist Disarticulation and Transradial Amputation, sponsored by Phantom Neuro Inc.. Recruiting at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Phantom Neuro Inc. · Not applicable, Interventional, and Device feasibility
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.
This early-feasibility study will evaluate the safety and functional performance of the Phantom X Implantable EMG Sensor System in individuals with unilateral transradial amputation and wrist disarticulation. The system consists of an implanted EMG sensor array, an implanted telemetry module, and an external wearable interface that provides real-time muscle signals to a myoelectric prosthesis.
The study follows a prospective, single-arm, open label design. Participants will undergo surgical implantation followed by device activation, calibration, and integration with a compatible prosthetic hand. Study procedures include periodic assessments of EMG signal quality, standardized functional assessments, and patient reported outcomes including quality of life measures and user experience. Safety will be monitored through adverse-event reporting and system performance checks.
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This study's planned enrollment of 10 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
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Exclusion Criteria:
Device: Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control
Participants receive the Phantom X implantable EMG sensor array and telemetry module to enable myoelectric control of an upper-limb prosthesis.
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
Phantom X algorithm gesture accuracy
Classification accuracy of the Phantom X algorithm will be computed based on the number of correctly and incorrectly classified gestures and reported as a percentage
Time frame: 9 weeks and 21 weeks
Phantom X at-home wear duration
Average and standard deviation of at-home prosthesis wear duration for all participants will be computed
Time frame: 9 weeks and 21 weeks
At-home limb usage pattern using Inertial Measurement Unit (IMU) data
Active and inactive durations in hours per day for each limb will be computed for each participant
Time frame: 9 weeks and 21 weeks
Prosthesis control resolution
Resolution of Phantom X control system for controlling a myoelectric hand prosthesis will be characterized using Myoelectric Control Resolution Assessment (MCRA) instrument
Time frame: 9 weeks and 21 weeks
Number of system recalibration events
Number of Phantom X recalibrations per participant will be collected and used to compute average and standard deviation of recalibration events for all participants
Time frame: 9 weeks and 21 weeks
User Satisfaction
User Satisfaction with Phantom X system is characterized using following three standardized instruments: modified version of Orthotics Prosthetics User Survey (mOPUS, range: 0-100, Higher score is better), 5-level Quality of Life questionnaire (EQ-5D-5L, Higher score is better), Canadian Occupational Performance Measure (COPM, range:1-10, Higher score is better), and a study User Satisfaction Survey.
Time frame: 9 weeks and 21 weeks
Robustness of Phantom X system
Robustness of Phantom X system is characterized by recording problematic activities of daily living (REC-ADL) that participants have problem performing with their baseline myoelectric control system.
Time frame: 9 weeks and 21 weeks
Phantom X ease of use
Ease of use and intuitiveness of Phantom X system is characterized using NASA-Task Load Index (NASA-TLX) instrument.
Time frame: 9 weeks and 21 weeks
Phantom Limb Pain
Change in phantom limb pain is characterized post implant and compared with baseline using Questionnaire for Post-Amputation Pain (Q-PAP).
Time frame: 9 weeks and 21 weeks
Plan to share: Undecided — We may not share IPD because of concerns about protecting participants' privacy and confidentiality. Even though our participant data would be de-identified, there is a risk (especially with sensitive, rare, or detailed clinical data as would be the case for amputees in our study) that the individuals could be re-identified. Maintaining confidentiality and minimizing potential harm to participants may outweigh the benefits of data sharing.
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