Musculoskeletal DisorderNCT05926739
Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Musculoskeletal Disorders
A study testing Electrical stimulation and biofeedback with Phenix Liberty medical device in people with Musculoskeletal Disorder, run by Vivaltis at 1 site in France.
Trial summary
Evaluate the evolution of locomotor abilities in patients treated with functional electrostimulation and biofeedback (PHENIX LIBERTY VIVALTIS device) for musculoskeletal disorders of the knee and spine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Disorder
- What is being tested?
- Electrical stimulation and biofeedback with Phenix Liberty medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 19 Aug 2024to 18 Dec 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (between 18 and 65 years of age);
- Patient presenting at least one of the following symptoms related to a locomotor disorder of the knee and/or spine: pain, hypertonia, amyotrophy, mobility restriction, muscle weakness, reduction or loss of motor control, reduction in motor pattern, trophic anomaly;
- Patient able to make himself available to attend sessions regularly and is confident of being able to complete all sessions; ;
- Patient who has signed the study participation consent form;y;
- Patient physically and mentally willing and able, according to the investigator's judgment at the time of recruitment, to perform the procedures under study;
- Patient with social security coverage.
Who cannot join
- Patients with Stroke, Alzheimer's, multiple sclerosis, peripheral nervous system disorders, spinal cord injury or with cognitive and/or behavioural disorders likely, in the practitioner's judgement in the practitioner's judgement, interact with the self-assessment or biofeedback;
- Patients with hypersensitivity to electrostimulation;
- Patients who, in the 1 month prior to inclusion, have had injections of corticosteroids (e.g. hyaluronate) in the knee/spine concerned;
- Patients with an implanted pacemaker or spinal cord pacemaker;
- Pregnant at the time of the inclusion visit, or wishing to become pregnant during the treatment period;
- Patients who have renounced their liberty by administrative or judicial sentence, or under guardianship or limited judicial protection;
- Patient participating in another interventional clinical trial for the same pathology or testing/having tested an investigational drug in the 30 days prior to inclusion in the study;
- Patient unable to read or write French;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of the Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Locomotor Disorders
Evaluate the evolution of locomotor abilities in patients treated with functional electrostimulation and biofeedback (PHENIX LIBERTY VIVALTIS device) for musculoskeletal disorders of the knee and spine.
Does the use of the medical device in the treatment of musculoskeletal disorders lead to an improvement ?
Participants will use the medical device, which provides electrical stimulation, biofeedback and pressure biofeedback to re-educate the muscles of the knee and spine area and
Read the detailed description
Rational :
Today, musculoskeletal disorders (MSDs) are considered to be one of the world's leading pathologies. They are also the most widespread occupational pathology in Europe. MSDs include a variety of conditions affecting bones, joints, muscles and connective tissues. To treat these disorders, the guidelines recommend non-drug therapies as first-line treatments for chronic low-back pain and osteoarthritis pain, such as electrostimulation and biofeedback therapy.
In this context, the promoter wishes to carry out this study in order to reinforce the data currently available on the medical device PHENIX LIBERTY.
Design:
Prospective, interventional with non invasive and non burdensome procedure, non-comparative, multicenter, open-label study of a CE-marked medical device
Intervention :
As part of this clinical investigation, the medical device under investigation is used in accordance with its usual use, and the patient's therapeutic procedure includes additional, non-invasive procedures. These additional procedures relate to the addition of an end-of-life visit and validated questionnaires assessing functional deficiencies and impact on daily life.
The care will be conduct as follow:
- 1 inclusion visit (V0) (from 1 say to 15 days prior the the first functionnal therapeutic re-education session)
- 12 sessions of functional therapeutic re-education, during which the PHENIX LIBERTY device may be used. Sessions performed at regular intervals according to a schedule drawn up by the physiotherapist (between 6 and 8 weeks);
- 1 end visit (V13), 1 week after the 12th session to complet questionnaires
In total, the patient will be followed 11 weeks maximum
- Conditions
- Musculoskeletal Disorder
- Being tested
- Electrical stimulation and biofeedback with Phenix Liberty medical device
- Keywords
- Electrical stimulation, Biofeedback, Knee, Low Back Pain
- Medical subject headings
- Musculoskeletal Diseases, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation and biofeedback with Phenix Liberty medical deviceDevice
12 sessions of electrical stimulation and biofeedback performed between 6 and 8 weeks at regular intervals according to a schedule drawn up by the physiotherapist.
The patient will undergo 12 therapeutic functional reeducation sessions, at regular intervals according to a schedule drawn up by the physiotherapist, during which the PHENIX LIBERTY device may be used. The patients will complete questionnaires at the end of the care.
Overall, the functional rehabilitation sessions will include muscle testing, electrostimulation and biofeedback.
The follow up will be conduct as follow :
- 12 sessions between 6 and 8 weeks
- 1 end visit, within the week after the 12th session
| Study group | Role | What they receive |
|---|---|---|
| Standard of care plus additional questionaire | Other | As part of this clinical investigation, the medical device under investigation is used in accordance with its usual use, and the patient's therapeutic procedure includes additional, non-invasive procedures. These additional procedures relate to the addition of an endof- life visit and validated questionnaires assessing functional deficiencies and impact on daily life. Receives: Device: Electrical stimulation and biofeedback with Phenix Liberty medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Lower Extremity Functional Scale (LEFS) score on the impact of locomotor disorders of the knee
The Lower Extremity Functional Scale (LEFS) is used by physiotherapists and occupational therapists in many clinical settings. It is an English-language measurement tool that collects psychometric data and assesses the functional status of the lower limbs. It consists of 20 questions on the level of difficulty experienced during everyday activities.
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Mean change in the Oswestry Disability Index (ODI) score for the impact of locomotor disorders of the spine.
The ODI will be used to assess the disability caused by Lower Back Pain (LBP)
The Oswestry Disability Index (ODI), a patient-completed questionnaire that gives a subjective percentage score of the level of function (disability) in activities of daily living in people undergoing rehabilitation after low back pain. The questionnaire examines the level of disability in 10 activities of daily living. Each item consists of 6 statements rated from 0 to 5. With 0 indicating the lowest level of disability and 5 the highest, the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability.
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Secondary outcomes (13)
Change in patients' visual analog scale (VAS) pain scores for knee pain and/or spine pain at rest and on palpation
The pain caused by the TMS of the knee and/or the spine will be assessed by the Visual Analogue Scale (VAS).
The VAS is made up of a 10-centimeter line anchored by two ends of the pain. 10 is the first end being the "maximum pain imaginable" and 0 is the other end being "no pain"
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Trends in consumption of painkillers and anti-inflammatories
Rate of consuption of painkillers and anti-inflammatories
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes in the rate of improvement of hypertonia of the concerned area (knee or spine) through measurement of myoelectric activity
A surface Electromyography (EMG) will be used. Muscle electrical activity provides a "map" of muscle recruitment according to exercise conditions (position, relative load, type of resistance, type of support, etc.).
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes in the rate of improvement of hypertonia of the concerned area (knee or spine) through Oxford Grading Scale
The Oxford scale is commonly used to manually assess muscle strength, and can help diagnose problems in which weakness plays a role. According to the Oxford scale, muscle strength is rated from 0 to 5 (0 being no muscle contraction > 5 being movement through a full range against full resistance). Scoring is as follows: 0 → No visible or palpable contraction, 1 → Visible/palpable muscle contraction but no movement, 2 → Movement across full range with gravity eliminated (low strength), 3 → Movement across full range against gravity only (fair strength), 4 → Movement across full range against gravity with some resistance (good strength), 5 → Movement across full range against gravity with full resistance (normal strength).
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes in the rate of improvement in awakening and muscle strengthening through Oxford grading scale
The Oxford scale is commonly used to manually assess muscle strength, and can help diagnose problems in which weakness plays a role. According to the Oxford scale, muscle strength is rated from 0 to 5 (0 being no muscle contraction > 5 being movement through a full range against full resistance). Scoring is as follows: 0 → No visible or palpable contraction, 1 → Visible/palpable muscle contraction but no movement, 2 → Movement across full range with gravity eliminated (low strength), 3 → Movement across full range against gravity only (fair strength), 4 → Movement across full range against gravity with some resistance (good strength), 5 → Movement across full range against gravity with full resistance (normal strength).
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes in the rate of improvement in awakening and muscle strengthening through measurement of myoelectric activity
A surface Electromyography (EMG) will be used. Muscle electrical activity provides a "map" of muscle recruitment according to exercise conditions (position, relative load, type of resistance, type of support, etc.).
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes of microcirculation of the concerned spine area
Assessment on the basis of clinical palpation examination done by the practitioner
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes of the microcirculation of the concerned knee area
The measurement of the muscular perimeter around the concerned knee will be assessed by a tape measure
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes of the improvement of the motor control through the measurement of myoelectrical activity
A surface Electromyography (EMG) will be used. Muscle electrical activity provides a "map" of muscle recruitment according to exercise conditions (position, relative load, type of resistance, type of support, etc.).
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Change in patient's quality of life
The SF-36 will be used to assess the quality of life score.
The SF-36, as described in the name, is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Pecentage of patients with an improvement in locomotor disorders
This outcome will be assessed according to the practitioner's opinion. Does the practitioner think that an improvement has been observed --> Yes / No ?
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Incidence of adverse events
Rate of the incidence of adverse events related to the medical device
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Evaluation of responses to the patient satisfaction questionnaire on the use of the PHENIX LIBERTY device after therapeutic management
The satisfaction questionnaire is constructed on the basis of the Likert Scale. The sponsor has written an questionnaire regarding the use of the Phenix Liberty for the patient. The Likert scale (or attitude scale) is a semantic rating system, generally consisting of 5 or 7 items, used in surveys to measure and evaluate perceptions, attitudes and opinions. The evaluation will be based on the following responses: Strongly agree (=5) ; Agree (=4) ; Rather agree (=3) ; Rather disagree (=2) ; Disagree (=1= ; Strongly disagree (=0). The minimum score 0 means a worse outcome and the maximum score 5 means a better outcome.
Measured: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start19 Aug 2024
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisorderStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivaltis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEISO, Human Physio
- Responsible party
- Sponsor
- Investigators
- Mathias Willame, Principal investigator, Human Physio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926739
- Sponsor's protocol ID
- 2023-A02460-45
- Status last verified
- Dec 2024
- First submitted
- 22 Jun 2023
- Last updated
- 24 Dec 2024
- 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Locomotor Disorders
- ClinicalTrials.gov ID
- NCT05926739
- Acronym / sponsor ID
- 2023-A02460-45
- Conditions
- Musculoskeletal Disorder
- Keywords
- Electrical stimulation, Biofeedback, Knee, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- VivaltisIndustry (pharma, biotech, devices)
- Collaborators
- CEISO, Human Physio
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 3 Jul 2023 (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.
Evaluate the evolution of locomotor abilities in patients treated with functional electrostimulation and biofeedback (PHENIX LIBERTY VIVALTIS device) for musculoskeletal disorders of the knee and spine.
Does the use of the medical device in the treatment of musculoskeletal disorders lead to an improvement ?
Participants will use the medical device, which provides electrical stimulation, biofeedback and pressure biofeedback to re-educate the muscles of the knee and spine area and
Detailed description
Rational :
Today, musculoskeletal disorders (MSDs) are considered to be one of the world's leading pathologies. They are also the most widespread occupational pathology in Europe. MSDs include a variety of conditions affecting bones, joints, muscles and connective tissues. To treat these disorders, the guidelines recommend non-drug therapies as first-line treatments for chronic low-back pain and osteoarthritis pain, such as electrostimulation and biofeedback therapy.
In this context, the promoter wishes to carry out this study in order to reinforce the data currently available on the medical device PHENIX LIBERTY.
Design:
Prospective, interventional with non invasive and non burdensome procedure, non-comparative, multicenter, open-label study of a CE-marked medical device
Intervention :
As part of this clinical investigation, the medical device under investigation is used in accordance with its usual use, and the patient's therapeutic procedure includes additional, non-invasive procedures. These additional procedures relate to the addition of an end-of-life visit and validated questionnaires assessing functional deficiencies and impact on daily life.
The care will be conduct as follow:
- 1 inclusion visit (V0) (from 1 say to 15 days prior the the first functionnal therapeutic re-education session)
- 12 sessions of functional therapeutic re-education, during which the PHENIX LIBERTY device may be used. Sessions performed at regular intervals according to a schedule drawn up by the physiotherapist (between 6 and 8 weeks);
- 1 end visit (V13), 1 week after the 12th session to complet questionnaires
In total, the patient will be followed 11 weeks maximum
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care plus additional questionaire | Other | Device: Electrical stimulation and biofeedback with Phenix Liberty medical deviceAs part of this clinical investigation, the medical device under investigation is used in accordance with its usual use, and the patient's therapeutic procedure includes additional, non-invasive procedures. These additional procedures relate to the addition of an endof- life visit and validated questionnaires assessing functional deficiencies and impact on daily life. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (between 18 and 65 years of age);
- Patient presenting at least one of the following symptoms related to a locomotor disorder of the knee and/or spine: pain, hypertonia, amyotrophy, mobility restriction, muscle weakness, reduction or loss of motor control, reduction in motor pattern, trophic anomaly;
- Patient able to make himself available to attend sessions regularly and is confident of being able to complete all sessions; ;
- Patient who has signed the study participation consent form;y;
- Patient physically and mentally willing and able, according to the investigator's judgment at the time of recruitment, to perform the procedures under study;
Key exclusion criteria (8 listed)
- Patients with Stroke, Alzheimer's, multiple sclerosis, peripheral nervous system disorders, spinal cord injury or with cognitive and/or behavioural disorders likely, in the practitioner's judgement in the practitioner's judgement, interact with the self-assessment or biofeedback;
- Patients with hypersensitivity to electrostimulation;
- Patients who, in the 1 month prior to inclusion, have had injections of corticosteroids (e.g. hyaluronate) in the knee/spine concerned;
- Patients with an implanted pacemaker or spinal cord pacemaker;
- Pregnant at the time of the inclusion visit, or wishing to become pregnant during the treatment period;
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 |
|---|---|---|
| Electrical stimulation and biofeedback with Phenix Liberty medical device12 sessions of electrical stimulation and biofeedback performed between 6 and 8 weeks at regular intervals according to a schedule drawn up by the physiotherapist. The patient will undergo 12 therapeutic functional reeducation sessions, at regular intervals according to a schedule drawn up by the physiotherapist, during which the PHENIX LIBERTY device may be used. The patients will complete questionnaires at the end of the care. Overall, the functional rehabilitation sessions will include muscle testing, electrostimulation and biofeedback. The follow up will be conduct as follow : * 12 sessions between 6 and 8 weeks * 1 end visit, within the week after the 12th session | Device | Standard of care plus additional questionaire |
Primary outcome
Mean change in Lower Extremity Functional Scale (LEFS) score on the impact of locomotor disorders of the knee
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
The Lower Extremity Functional Scale (LEFS) is used by physiotherapists and occupational therapists in many clinical settings. It is an English-language measurement tool that collects psychometric data and assesses the functional status of the lower limbs. It consists of 20 questions on the level of difficulty experienced during everyday activities.
Mean change in the Oswestry Disability Index (ODI) score for the impact of locomotor disorders of the spine.
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
The ODI will be used to assess the disability caused by Lower Back Pain (LBP) The Oswestry Disability Index (ODI), a patient-completed questionnaire that gives a subjective percentage score of the level of function (disability) in activities of daily living in people undergoing rehabilitation after low back pain. The questionnaire examines the level of disability in 10 activities of daily living. Each item consists of 6 statements rated from 0 to 5. With 0 indicating the lowest level of disability and 5 the highest, the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability.
13 secondary outcomes
Change in patients' visual analog scale (VAS) pain scores for knee pain and/or spine pain at rest and on palpation
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Trends in consumption of painkillers and anti-inflammatories
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes in the rate of improvement of hypertonia of the concerned area (knee or spine) through measurement of myoelectric activity
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes in the rate of improvement of hypertonia of the concerned area (knee or spine) through Oxford Grading Scale
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes in the rate of improvement in awakening and muscle strengthening through Oxford grading scale
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes in the rate of improvement in awakening and muscle strengthening through measurement of myoelectric activity
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes of microcirculation of the concerned spine area
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes of the microcirculation of the concerned knee area
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Changes of the improvement of the motor control through the measurement of myoelectrical activity
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Change in patient's quality of life
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Pecentage of patients with an improvement in locomotor disorders
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Incidence of adverse events
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Evaluation of responses to the patient satisfaction questionnaire on the use of the PHENIX LIBERTY device after therapeutic management
Time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
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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.
Mathias Willame principal investigator
Human Physio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation and biofeedback with Phenix Liberty medical device in people with Musculoskeletal Disorder, run by Vivaltis at 1 site in France.
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 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: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in Lower Extremity Functional Scale (LEFS) score on the impact of locomotor disorders of the knee (time frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)). 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 24 Dec 2024.