Congenital and Acquired Neuromotor DisordersNCT07092436
Pediatric Upper-Limb Rehabilitation With PhiCube, a Modular Bilateral End-Effector Device
A study testing Robotic bilateral upper limb rehabilitation training in people with Congenital and Acquired Neuromotor Disorders and Developmental Coordination Disorder (DCD), run by Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato at 6 sites in Italy.
Trial summary
The present investigation is configured as a multicenter clinical study in a within-group pilot phase. This study aims to investigate primarily the feasibility of use and effectiveness of a treatment for upper limb function in children aged 4 to 18 years with congenital and acquired neuromotor disorders through a new… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Congenital and Acquired Neuromotor Disorders, Developmental Coordination Disorder (DCD)
- What is being tested?
- Robotic bilateral upper limb rehabilitation training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesItaly
- Study dates
- 17 Nov 2025to Nov 2026
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- For subjects with congenital and acquired neuromotor disorders:
- Diagnosis of congenital and acquired neuromotor disorders
- Age between 4 and 18 years at the time of recruitment
- Modified Ashworth Scale (MAS) less than 3
- MACS level I-IV
- Sufficient capacity to understand the proposed activities
Show all 12Show fewer
- Availability to attend the facility
- For subjects with developmental coordination disorder (DCD):
- Diagnosis of developmental coordination disorder (DCD)
- Age between 4 and 18 years at the time of recruitment
- Sufficient capacity to understand the proposed activities
- Availability to attend the facility
Who cannot join
- For subjects with congenital and acquired neuromotor disorders:
- Severe sensory deficits
- Onset of pathologies that prevent participation
- Worsening of pre-existing comorbidities
- For subjects with developmental coordination disorder (DCD):
- Severe sensory deficits
- Onset of pathologies that prevent participation
- Worsening of pre-existing comorbidities
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Recruiting
IRCCS Eugenio Medea
Bosisio Parini, LC, 23842
Emilia Biffi, PhD, +39.031.877862, emilia.biffi@lanostrafamiglia.it
Eleonora Diella, MD
- Recruiting
IRCCS Fondazione Stella Maris
Calambrone, PI, 56128
Giuseppina Sgandurra, PhD, +39.050.886284, giuseppina.sgandurra@fsm.unipi.it
Giuseppina Sgandurra, PhD
- Recruiting
IRCCS Istituto Giannina Gaslini
Genova, 16147
Alessia Aiello, MD, +39.010.56363137, alessia.aiello@gaslini.org
Alessia Aiello, MD
- Recruiting
Fondazione Don Gnocchi IRCCS - Centro Santa Maria Nascente
Milan, 20148
Angela Cavalagli, MD, +39.02.40308279, acavalagli@dongnocchi.it
Angela Cavalagli, MD
- Recruiting
IRCCS Fondazione Mondino
Pavia, 27100
Sabrina Signorini, MD, +39.0382.380233
Sabrina Signorini, MD
- Recruiting
Fondazione Don Gnocchi - Centro S. Maria al Mare
Salerno, SA, 84131
Marco Germanotta, PhD, +39.089.334425, mgermanotta@dongnocchi.it
Irene Giovanna Aprile, PhD
About this study
Official title: Pediatric Upper-Limb Rehabilitation With PhiCube, a Modular Bilateral End-Effector Device.
The present investigation is configured as a multicenter clinical study in a within-group pilot phase.
This study aims to investigate primarily the feasibility of use and effectiveness of a treatment for upper limb function in children aged 4 to 18 years with congenital and acquired neuromotor disorders through a new portable robotic system, called PhiCube, designed for bilateral neuromotor rehabilitation of the upper limbs in subjects with neuromotor disorders.
Read more
In order to specifically investigate also the potential impact of PhiCube on movement planning aspects, the study will also involve a small group of children aged 4 to 18 years with Developmental Coordination Disorder (DCD).
Before (PreT0 and T0) and after (T1 and T2) treatment, standardized assessment tests will be administered. Regarding the investigation objectives reported above, the primary outcome measure will be the Melbourne Assessment-2 (MA2), a standardized, valid and reliable instrument for evaluating the quality of upper limb movement in children with neurological deficits, capable of measuring four elements of movement quality: range of motion, accuracy, dexterity and fluency. As secondary outcome measures, Abilhand-Kids has been chosen, a brief questionnaire that measures 21 main daily bimanual activities completed by the parent or caregiver, and various subtests and questionnaires aimed at evaluating the neuropsychological processes involved and the effects related to auditory feedback perception.
The treatment will have a total duration of approximately 3 months and will be organized in 3 weekly sessions lasting 45 minutes each, to reach a total of 30.
Descriptive statistics of the clinical and technological variables obtained in the evaluation and rehabilitation phases will be calculated. Subsequently, treatment efficacy analyses through the robotic device are planned, comparing pre-post clinical variables. All collected data will finally be analyzed in order to compare the rehabilitative efficacy of the device with respect to the different groups of participants identified based on diagnostic profile.
- Being tested
- Robotic bilateral upper limb rehabilitation training
- Keywords
- Pediatric Rehabilitation, Upper Limb Rehabilitation, Robotic Rehabilitation, Bilateral Training, Neuromotor Disorders
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic bilateral upper limb rehabilitation trainingDevice
Bilateral upper limb rehabilitation using PhiCube, a modular robotic end-effector device with two motorized axes that can assist or resist patient movements. Treatment consists of 30 sessions over 3 months (3 sessions/week, 45 minutes each) combining motor training with gaming elements specifically designed for pediatric populations. The device's modular design allows customization for individual patient needs and bilateral coordination training. Sessions focus on improving range of motion, precision, dexterity, and movement fluidity through controlled, repetitive, high-intensity exercises in children aged 4-18 years with neuromotor disorders and developmental coordination disorder.
| Study group | Role | What they receive |
|---|---|---|
| PhiCube Bilateral Upper Limb Rehabilitation | Experimental | Not described Receives: Device: Robotic bilateral upper limb rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb movement quality in children with neurological deficits
Quality of upper limb movement in children with neurological deficits, measured through Melbourne Assessment-2 (MA2), which is able to measure four elements of movement quality: range of motion, precision, dexterity and fluidity.
Measured: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
Secondary outcomes (16)
ABILHAND-Kids Questionnaire
A brief questionnaire measuring 21 main bimanual daily activities. Scores are assigned by parents based on the child's difficulty in performing daily activities, with a 3-point scale (impossible, difficult, easy).
Measured: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
Leiter-3 Sustained Attention Subtest
A subtest of the Leiter-3 non-verbal cognitive scale that evaluates sustained visual attention through tasks of increasing complexity within a specific time period. The number of correctly selected target elements is recorded.
Measured: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Inhibition Subtest
Evaluates inhibitory control abilities of automatic verbal responses through administration of 3 different conditions for two different stimulus sets, requiring naming, inhibition with reversal, and alternating responses based on color.
Measured: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Auditory Attention Subtest
Assesses the ability to maintain sustained attention to auditory stimuli performance and inhibit automatic motor responses in two tasks of increasing complexity with incremental executive control demands.
Measured: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Manual Posture Imitation subtest
This subtest assesses the child's ability to accurately imitate a series of progressively complex hand and finger postures demonstrated by the examiner. The raw score is obtained by summing the number of correctly executed postures, separately recorded for the dominant and non-dominant hands. From the total raw score, a weighted score is derived, which in turn is used to calculate the standard score based on normative data.
Measured: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Manual Motor Sequences subtest
This subtest evaluates the child's ability to observe and reproduce sequences of hand movements demonstrated by the examiner. The sequences become progressively more complex and require the integration of motor planning, attention, and imitation abilities. The raw score is calculated by summing the number of correctly imitated sequences. From the total raw score, a weighted score is derived, which is then converted into a standard score based on normative data.
Measured: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Arrow subtest
This subtests evaluates the ability to judge line orientation considering direction, distance, orientation, and angularity. The task requires the integration of visual attention, orientation discrimination, and mental rotation.
The raw score is obtained by summing the number of correct responses across all items. From this total raw score, a weighted score is calculated and then converted into a standard score based on age-specific normative data.
Measured: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Route Finding subtest
This subtest assesses the ability to use a small schematic map to locate targets on a larger schematic map.
The raw score corresponds to the number of correctly identified routes. From this raw score, a weighted score is derived and then transformed into a standard score using normative tables based on the child's age.
Measured: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
BRIEF P/2 Questionnaire
Parent-administered questionnaire evaluating executive functions in daily life contexts. Parents rate behaviors on a 3-point Likert scale based on frequency over the past six months.
Measured: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
Usability questionnaire
Custom questionnaire administered to stakeholders (children and operators) at treatment completion to investigate system usability.
Measured: T1: Immediately after completing the treatment period
Acceptability questionnaire
Custom questionnaire administered to stakeholders (children and operators) at treatment completion to investigate system acceptability.
Measured: T1: Immediately after completing the treatment period
Compliance questionnaire
Custom questionnaire administered to stakeholders (children and operators) at treatment completion to investigate child and operator compliance.
Measured: T1: Immediately after completing the treatment period
Movement smoothness
Measures of how continuous and even a movement is, without sudden stops or changes in speed. It is measured by the normalized jerk.
Measured: - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period
Trajectory error
Measures the error made by one limb in following a proposed trajectory via the screen.
Measured: - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period
Bilateral coordination
Measures coordination between limbs in performing the same movement simultaneously by calculating the difference between axes coordinates.
Measured: - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period
Audio Feedback Effect Evaluation
Assessment of how audio feedback influences motivational and satisfaction aspects through three interaction conditions (no feedback, reward feedback, help feedback) using VAS scales for fun and engagement, adapted In-game Questionnaire, and open-ended questions about the child's experience.
Measured: - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start17 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital and Acquired Neuromotor DisordersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Fondazione Stella Maris, IRCCS Eugenio Medea, Fondazione Don Carlo Gnocchi ETS, IRCCS Fondazione Istituto Neurologico Mondino Pavia, Ospedale IRCCS G. Gaslini di Genova
- Responsible party
- Sponsor
- Investigators
- Giuseppina Sgandurra, PhD, Study chair, IRCCS Fondazione Stella Maris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092436
- Sponsor's protocol ID
- PhiCube-Pediatric
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Upper-Limb Rehabilitation With PhiCube, a Modular Bilateral End-Effector Device.
- ClinicalTrials.gov ID
- NCT07092436
- Acronym / sponsor ID
- PhiCube-Pediatric
- Keywords
- Pediatric Rehabilitation, Upper Limb Rehabilitation, Robotic Rehabilitation, Bilateral Training, Neuromotor Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero AvanzatoUniversity, hospital or other
- Collaborators
- IRCCS Fondazione Stella Maris, IRCCS Eugenio Medea, Fondazione Don Carlo Gnocchi ETS, IRCCS Fondazione Istituto Neurologico Mondino Pavia, Ospedale IRCCS G. Gaslini di Genova
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 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.
The present investigation is configured as a multicenter clinical study in a within-group pilot phase.
This study aims to investigate primarily the feasibility of use and effectiveness of a treatment for upper limb function in children aged 4 to 18 years with congenital and acquired neuromotor disorders through a new portable robotic system, called PhiCube, designed for bilateral neuromotor rehabilitation of the upper limbs in subjects with neuromotor disorders.
In order to specifically investigate also the potential impact of PhiCube on movement planning aspects, the study will also involve a small group of children aged 4 to 18 years with Developmental Coordination Disorder (DCD).
Before (PreT0 and T0) and after (T1 and T2) treatment, standardized assessment tests will be administered. Regarding the investigation objectives reported above, the primary outcome measure will be the Melbourne Assessment-2 (MA2), a standardized, valid and reliable instrument for evaluating the quality of upper limb movement in children with neurological deficits, capable of measuring four elements of movement quality: range of motion, accuracy, dexterity and fluency. As secondary outcome measures, Abilhand-Kids has been chosen, a brief questionnaire that measures 21 main daily bimanual activities completed by the parent or caregiver, and various subtests and questionnaires aimed at evaluating the neuropsychological processes involved and the effects related to auditory feedback perception.
The treatment will have a total duration of approximately 3 months and will be organized in 3 weekly sessions lasting 45 minutes each, to reach a total of 30.
Descriptive statistics of the clinical and technological variables obtained in the evaluation and rehabilitation phases will be calculated. Subsequently, treatment efficacy analyses through the robotic device are planned, comparing pre-post clinical variables. All collected data will finally be analyzed in order to compare the rehabilitative efficacy of the device with respect to the different groups of participants identified based on diagnostic profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PhiCube Bilateral Upper Limb Rehabilitation | Experimental | Device: Robotic bilateral upper limb rehabilitation training |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- For subjects with congenital and acquired neuromotor disorders:
- For subjects with developmental coordination disorder (DCD):
Key exclusion criteria (8 listed)
- For subjects with congenital and acquired neuromotor disorders:
- For subjects with developmental coordination disorder (DCD):
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 |
|---|---|---|
| Robotic bilateral upper limb rehabilitation trainingBilateral upper limb rehabilitation using PhiCube, a modular robotic end-effector device with two motorized axes that can assist or resist patient movements. Treatment consists of 30 sessions over 3 months (3 sessions/week, 45 minutes each) combining motor training with gaming elements specifically designed for pediatric populations. The device's modular design allows customization for individual patient needs and bilateral coordination training. Sessions focus on improving range of motion, precision, dexterity, and movement fluidity through controlled, repetitive, high-intensity exercises in children aged 4-18 years with neuromotor disorders and developmental coordination disorder. | Device | PhiCube Bilateral Upper Limb Rehabilitation |
Primary outcome
Upper limb movement quality in children with neurological deficits
Time frame: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
Quality of upper limb movement in children with neurological deficits, measured through Melbourne Assessment-2 (MA2), which is able to measure four elements of movement quality: range of motion, precision, dexterity and fluidity.
16 secondary outcomes
ABILHAND-Kids Questionnaire
Time frame: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
Leiter-3 Sustained Attention Subtest
Time frame: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Inhibition Subtest
Time frame: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Auditory Attention Subtest
Time frame: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Manual Posture Imitation subtest
Time frame: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Manual Motor Sequences subtest
Time frame: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Arrow subtest
Time frame: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
NEPSY-II Route Finding subtest
Time frame: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
BRIEF P/2 Questionnaire
Time frame: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion
Usability questionnaire
Time frame: T1: Immediately after completing the treatment period
Acceptability questionnaire
Time frame: T1: Immediately after completing the treatment period
Compliance questionnaire
Time frame: T1: Immediately after completing the treatment period
Movement smoothness
Time frame: - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period
Trajectory error
Time frame: - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period
Bilateral coordination
Time frame: - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period
Audio Feedback Effect Evaluation
Time frame: - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period
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 2 Apr 2026.
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Neuromotor Impairments, Cerebral Palsy
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.
Giuseppina Sgandurra, PhD study chair
IRCCS Fondazione Stella Maris
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic bilateral upper limb rehabilitation training in people with Congenital and Acquired Neuromotor Disorders and Developmental Coordination Disorder (DCD), run by Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato at 6 sites in Italy.
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 12 inclusion and 8 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 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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 Matteo Malosio, PhD (+39.0341.235.0203, matteo.malosio@cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb movement quality in children with neurological deficits (time frame: Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion). 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 2 Apr 2026.