Upper Limb Amputation Below ElbowEMPOWERNCT07071584
Evaluation of a Multi-electrode Prosthesis Control System for Real-world Tasks Performance in Individuals With Upper Limb Transradial Amputation
A study of Upper Limb Amputation Below Elbow, run by Phantom Neuro Inc. at 2 sites in United States.
Trial summary
This study tests how well the Phantom X prosthesis control system works. The system helps control a prosthetic hand using muscle signals from the arm. You'll wear a non-invasive version for one day in the clinic. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Upper Limb Amputation Below Elbow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals 21 years in age and older
- Individuals with unilateral or bilateral amputation at transradial level
- Patient is willing to comply with study protocol and make required study visits
- Willingness and ability to sign Informed Consent
Who cannot join
- Cognitively impaired to follow study instructions
- Allergies to skin adhesive materials necessary for cutaneous electrode placement
- Excessive hair growth on arms and inability to shave off the hair for electrode placement
- Pregnant woman
- Residual limbs of insufficient diameter or length to accommodate the wearing of two cutaneous sensor arrays
- Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Phantom Neuro Inc. Operational Headquarters
Austin, Texas, 78701
Atlas Ambulatory Surgery Center
Buffalo, New York, 14221
About this study
Official title: Evaluation of a Multi-electrode Prosthesis Control System for Real-World Tasks Performance
This study tests how well the Phantom X prosthesis control system works. The system helps control a prosthetic hand using muscle signals from the arm. You'll wear a non-invasive version for one day in the clinic. You'll practice hand movements and then do two simple tasks with both your usual prosthesis and the Phantom X system. At the end, you'll fill out short surveys about your experience.
Read the detailed description
The goal of this study is to evaluate the functional performance of the Phantom X prosthesis control system using a non-invasive version of its 32-electrode sensor array. All other components, including the Fusion Port, will be in their final clinical form factor, consistent with those used in future implantable configurations. The study will take place during a single, in-clinic session. Informed consent will be obtained either remotely prior to the visit or at the start of the session. Participants will undergo an initial EMG screening to determine signal suitability. Those with insufficient signal quality will be excluded. Eligible participants will be fitted with a universal socket, prosthesis, and the Phantom X system. Accelerometers will be placed on both limbs for movement tracking. Participants will practice a predefined set of gestures, followed by system calibration. Two validated functional assessments, Assessment of Capacity for Myoelectric Control (ACMC) and Targeted Box and Blocks Test (tBBT), will be conducted under two conditions: with the participant's baseline setup (if applicable) and with Phantom X. The testing order will be randomized. Participants will complete a user satisfaction questionnaire and NASA Task Load Index instrument to measure intuitiveness of Phantom X system before exiting the study.
- Conditions
- Upper Limb Amputation Below Elbow
- Being tested
- Cutaneous Prosthesis Control System
- Keywords
- Myoelectric control, Transradial amputee, Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutaneous Prosthesis Control SystemDevice
Prosthesis control system using a multi-electrode cutaneous sensor array
| Study group | Role | What they receive |
|---|---|---|
| Participants instrumented with cutaneous version of Phantom X system using a universal socket | Experimental | With Phantom X system instrumented, participants will perform the following two assessments: ACMC and tBBT. They will also complete user satisfaction and NASA-TLX questionaries. Receives: Device: Cutaneous Prosthesis Control System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Phantom X Prosthesis Control System in performing activities of daily living (ADL)
Feasibility of prosthesis control will be assessed using Assessment of Capacity of Myoelectric Control (ACMC) and while participants perform predefined ADL tasks. ACMC score ranges from 0-100, higher score suggesting better prosthesis myoelectric control.
Measured: Through study completion, average of 1 day
Feasibility of Phantom X Prosthesis Control System in performing repeated task requiring hand dexterity
Feasibility of Phantom X system in performing repeated task requiring prosthetic hand's dexterity will be assessed using Targeted Box and Blocks Test (tBBT) in which participants will transfer numbered blocks from one compartment to corresponding spots in a second adjacent compartment. tBBT is scored by measuring time taken to complete block transfer from one compartment to another. Lower completion time suggests better performance.
Measured: Through study completion, average of 1 day
Secondary outcomes (2)
Satisfaction of prosthesis control with Phantom X system
Participant satisfaction in using the Phantom X control system will be collected using a questionnaire
Measured: Through study completion, average of 1 day
Intuitiveness of prosthesis control using Phantom X system
Intuitiveness of prosthesis control with Phantom X control system will be evaluated using NASA-Task Load Index instrument (NASA-TLX)
Measured: Through study completion, average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start15 Aug 2025
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: The study was stopped because of recruitment challenges and sponsor's decision to pivot to a new study outside the US
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 ElbowStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phantom Neuro Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlas Ambulatory Surgery Center
- Responsible party
- Sponsor
- Investigators
- Elad Levy, MD, Principal investigator, Atlas Ambulatory Surgery Center, Buffalo, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071584
- Sponsor's protocol ID
- PN02
- Acronym
- EMPOWER
- Status last verified
- Dec 2025
- First submitted
- 19 Jun 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multi-electrode Prosthesis Control System for Real-World Tasks Performance
- ClinicalTrials.gov ID
- NCT07071584
- Acronym / sponsor ID
- EMPOWER / PN02
- Conditions
- Upper Limb Amputation Below Elbow
- Keywords
- Myoelectric control, Transradial amputee, Prosthesis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped because of recruitment challenges and sponsor's decision to pivot to a new study outside the US
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Phantom Neuro Inc.Industry (pharma, biotech, devices)
- Collaborators
- Atlas Ambulatory Surgery Center
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 17 Jul 2025 (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.
This study tests how well the Phantom X prosthesis control system works. The system helps control a prosthetic hand using muscle signals from the arm. You'll wear a non-invasive version for one day in the clinic. You'll practice hand movements and then do two simple tasks with both your usual prosthesis and the Phantom X system. At the end, you'll fill out short surveys about your experience.
Detailed description
The goal of this study is to evaluate the functional performance of the Phantom X prosthesis control system using a non-invasive version of its 32-electrode sensor array. All other components, including the Fusion Port, will be in their final clinical form factor, consistent with those used in future implantable configurations. The study will take place during a single, in-clinic session. Informed consent will be obtained either remotely prior to the visit or at the start of the session. Participants will undergo an initial EMG screening to determine signal suitability. Those with insufficient signal quality will be excluded. Eligible participants will be fitted with a universal socket, prosthesis, and the Phantom X system. Accelerometers will be placed on both limbs for movement tracking. Participants will practice a predefined set of gestures, followed by system calibration. Two validated functional assessments, Assessment of Capacity for Myoelectric Control (ACMC) and Targeted Box and Blocks Test (tBBT), will be conducted under two conditions: with the participant's baseline setup (if applicable) and with Phantom X. The testing order will be randomized. Participants will complete a user satisfaction questionnaire and NASA Task Load Index instrument to measure intuitiveness of Phantom X system before exiting the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants instrumented with cutaneous version of Phantom X system using a universal socket | Experimental | Device: Cutaneous Prosthesis Control SystemWith Phantom X system instrumented, participants will perform the following two assessments: ACMC and tBBT. They will also complete user satisfaction and NASA-TLX questionaries. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals 21 years in age and older
- Individuals with unilateral or bilateral amputation at transradial level
- Patient is willing to comply with study protocol and make required study visits
- Willingness and ability to sign Informed Consent
Key exclusion criteria (6 listed)
- Cognitively impaired to follow study instructions
- Allergies to skin adhesive materials necessary for cutaneous electrode placement
- Excessive hair growth on arms and inability to shave off the hair for electrode placement
- Pregnant woman
- Residual limbs of insufficient diameter or length to accommodate the wearing of two cutaneous sensor arrays
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 |
|---|---|---|
| Cutaneous Prosthesis Control SystemProsthesis control system using a multi-electrode cutaneous sensor array | Device | Participants instrumented with cutaneous version of Phantom X system using a universal socket |
Primary outcome
Feasibility of Phantom X Prosthesis Control System in performing activities of daily living (ADL)
Time frame: Through study completion, average of 1 day
Feasibility of prosthesis control will be assessed using Assessment of Capacity of Myoelectric Control (ACMC) and while participants perform predefined ADL tasks. ACMC score ranges from 0-100, higher score suggesting better prosthesis myoelectric control.
Feasibility of Phantom X Prosthesis Control System in performing repeated task requiring hand dexterity
Time frame: Through study completion, average of 1 day
Feasibility of Phantom X system in performing repeated task requiring prosthetic hand's dexterity will be assessed using Targeted Box and Blocks Test (tBBT) in which participants will transfer numbered blocks from one compartment to corresponding spots in a second adjacent compartment. tBBT is scored by measuring time taken to complete block transfer from one compartment to another. Lower completion time suggests better performance.
2 secondary outcomes
Satisfaction of prosthesis control with Phantom X system
Time frame: Through study completion, average of 1 day
Intuitiveness of prosthesis control using Phantom X system
Time frame: Through study completion, average of 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Elad Levy, MD principal investigator
Atlas Ambulatory Surgery Center, Buffalo, NY
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, run by Phantom Neuro Inc. at 2 sites in United States.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 13 Feb 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Phantom X Prosthesis Control System in performing activities of daily living (ADL) (time frame: Through study completion, average of 1 day). The study lists 2 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 13 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.