Upper Limb Amputation Below Elbow (Injury)CYBORGNCT07325708
Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control
A study of Upper Limb Amputation Below Elbow (Injury) and Wrist Disarticulation, run by Phantom Neuro Inc. at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Amputation Below Elbow (Injury), Wrist Disarticulation, Transradial Amputation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesAustralia
- Study dates
- 17 Apr 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Cabrini Health Ltd
Malvern, Victoria, 3189
Michael Lo, MBBS, FRACS, BSc (Hons), +61 039-509-7802, mlo@bigpond.net.au
- Recruiting
ProMotion Prosthetics Pty Ltd
Moorabbin, Victoria, 3189
Michael Lo, MSc, Dip.App.Sci, +61 039-532-5098, davidlg@pmprosthetics.com.au
About this study
Official title: Clinical Evaluation of System for Bionic Arm Gesture Control (CYBORG)
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.
Read the detailed description
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.
- Being tested
- Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control
- Keywords
- Upper limb amputation, Prosthesis, Myoelectric
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phantom X multielectrode EMG sensor array implant for upper limb prosthesis controlDevice
Participants receive the Phantom X implantable EMG sensor array and telemetry module to enable myoelectric control of an upper-limb prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Phantom X | Experimental | Not described Receives: Device: Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 9 weeks
Secondary outcomes (13)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 9 weeks and 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start17 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Amputation Below Elbow (Injury)Studies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phantom Neuro Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cabrini Health, Melbourne, Australia, ProMotion Prosthetics, Moorabbin, Australia
- Responsible party
- Sponsor
- Investigators
- Michael Lo, MBBS, FRACS, BSc (Hons), Principal investigator, Cabrini Private Hospital, Malvern, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325708
- Sponsor's protocol ID
- PN03
- Acronym
- CYBORG
- Status last verified
- Jun 2026
- First submitted
- 7 Dec 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of System for Bionic Arm Gesture Control (CYBORG)
- ClinicalTrials.gov ID
- NCT07325708
- Acronym / sponsor ID
- CYBORG / PN03
- Keywords
- Upper limb amputation, Prosthesis, Myoelectric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Phantom Neuro Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cabrini Health, Melbourne, Australia, ProMotion Prosthetics, Moorabbin, Australia
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phantom X | Experimental | Device: Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phantom X multielectrode EMG sensor array implant for upper limb prosthesis controlParticipants receive the Phantom X implantable EMG sensor array and telemetry module to enable myoelectric control of an upper-limb prosthesis. | Device | Phantom X |
Primary outcome
Safety of Phantom X system during the implantation procedure, peri-procedurally, and 9 weeks thereafter
Time frame: 9 weeks
Safety is characterized by collecting device and procedure related adverse events during device implantation and 9-week study follow-up.
Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument
Time frame: 9 weeks
Average and standard deviation of ACMC scores will be computed for all participants
Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument
Time frame: 9 weeks
Average and standard deviation of tBBT scores will be computed for all participants
13 secondary outcomes
Safety of Phantom X system during the implantation procedure, peri-procedurally, and 21 weeks thereafter
Time frame: 21 weeks
Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument
Time frame: 21 weeks
Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument
Time frame: 21 weeks
Phantom X Signal-to-Noise Ratio (SNR)
Time frame: 9 weeks and 21 weeks
Phantom X algorithm gesture accuracy
Time frame: 9 weeks and 21 weeks
Phantom X at-home wear duration
Time frame: 9 weeks and 21 weeks
At-home limb usage pattern using Inertial Measurement Unit (IMU) data
Time frame: 9 weeks and 21 weeks
Prosthesis control resolution
Time frame: 9 weeks and 21 weeks
Number of system recalibration events
Time frame: 9 weeks and 21 weeks
User Satisfaction
Time frame: 9 weeks and 21 weeks
Robustness of Phantom X system
Time frame: 9 weeks and 21 weeks
Phantom X ease of use
Time frame: 9 weeks and 21 weeks
Phantom Limb Pain
Time frame: 9 weeks and 21 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Lo, MBBS, FRACS, BSc (Hons) principal investigator
Cabrini Private Hospital, Malvern, Australia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Upper Limb Amputation Below Elbow (Injury) and Wrist Disarticulation, run by Phantom Neuro Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vinod Sharma, PhD (+1 512-763-0152, vinod@phantomneuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Phantom X system during the implantation procedure, peri-procedurally, and 9 weeks thereafter (time frame: 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.