Mollii SuitNCT06259864
Effects of Mollii Suit in Children With Non-Ambule Cerebral Palsy
A study testing EXOPULSE Mollii Suit method in people with Mollii Suit and Cerebral Palsy, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to examine the effectiveness of the Mollii Suit application on gross motor function, spasticity, postural control, upper extremity skills, selective motor control, daily living activities, quality of life, pain, sleep, constipation and drooling problems in non-ambulatory individuals with… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Mollii Suit, Cerebral Palsy
- What is being tested?
- EXOPULSE Mollii Suit method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2024to 30 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GMFCS 4 or 5 with spastic cerebral palsy children
- Volunteering to participate in the study
Who cannot join
- Botulinum toxinA injection in the last 3 months
- Surgical intervention involving the musculoskeletal system in the last 6 months
- Having an invasive medical pump (baclofen, insulin, etc.)
Trial locations and contacts
1 site in 1 country.
Bülent Elbasan contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara
Kübra Uğurlu, +0905077295353, kubra.zodamar06@gmail.com
About this study
Official title: Examining the Efficacy of Mollii Suit in Children With Non-Ambule Cerebral Palsy: A Single Blind Randomized Controlled Study.
The aim of our study is to examine the effectiveness of the Mollii Suit application on gross motor function, spasticity, postural control, upper extremity skills, selective motor control, daily living activities, quality of life, pain, sleep, constipation and drooling problems in non-ambulatory individuals with cerebral palsy (CP).
Read the detailed description
Our study includes children diagnosed with spastic type cerebral palsy at GMFCS level 4 or 5 who applied to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.
After the patients are separated according to the specified exclusion and inclusion criteria, they will be divided into two groups by simple randomization method.
Evaluations will be made before and after treatment. In addition to normal neurodevelopmental therapy (NGT) and Mollii Suit method will be applied 2 days a week. The total duration of treatment will take 8 weeks. Groups; The first group will consist of children with CP who will receive neurodevelopmental treatment.
The second group will consist of children who will receive the Molli Suit method in addition to neurodevelopmental treatment.
- Conditions
- Mollii Suit, Cerebral Palsy
- Being tested
- EXOPULSE Mollii Suit method
- Keywords
- cerebral palsy, mollii suit, spasticity, salivation, constipation, gross motor function, quality of life
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Sialorrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOPULSE Mollii Suit methodOther
EXOPULSE Mollii Suit method, one of the newest rehabilitation technology products, is a non-invasive neuromodulation approach with a garment that covers the whole body and electrodes placed inside. Designed to improve motor function by reducing spasticity and pain, the method is based on the principle of reciprocal inhibition, which occurs by stimulating the antagonist of a spastic muscle at low frequencies and intensities.
| Study group | Role | What they receive |
|---|---|---|
| Neurodevelopmental treatment program group | Active comparator | NDT aims to bring the child to the maximum level of independence possible within the limits of age and ability. Treatment sessions are planned for a certain functional result, and the patient's active participation as much as possible is requested. As the child fulfills postural and motor requirements, the physical therapist provides less assistance and less guidance. Positionings supported by auxiliary materials, appropriate hand contacts, correct ways to hold the child, tonus regulation, family education, environmental regulations and goal-oriented quality movement approaches; These are some of the methods used by the NDT approach, which is based on facilitation, stimulation and communication. Neurodevelopmental treatment physiotherapy session for 2 days in a week, over 8 week. Receives: Other: EXOPULSE Mollii Suit method |
| Mollii Suit method group | Experimental | The Exopulse Mollii Suit is designed to restore normality and healthy balance of muscle groups in the body. The suite uses one of several different forms of neuromodulation, based on gently stimulating the affected muscle groups with electrical signals. This approach has been shown to help resynchronize muscle signals that have been disrupted due to spasticity and muscle groups that may have stopped working together. 58 electrodes embedded in the suit send mild and imperceptible impulses to both tense and spastic muscles and the weakened muscles that balance them. These stimulations not only relax tense muscles and reactivate weak ones, but also restore the natural balance of the group and help the body move as it should. Children will wear the outfit twice a week for 8 weeks and each session will last 60 minutes. During this practice, children will also receive NDT twice a week. Receives: Other: EXOPULSE Mollii Suit method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure
GMFM evaluates children's motor activities in 5 different positions called 'lying down and rolling over', 'crawling and kneeling down', 'sitting', 'standing' and 'walking, running, jumping' on a scale of 0-3 (0: unable to initiate movement. 3: independent movement). It is a measurement method that scores.
Measured: 15 minutes
Modified Tradiue Scale
Modified Tardiue Scale (MTS) will be used in the evaluation of spasticity. MTS is a method that evaluates the velocity-sensitive nature of spasticity through passive movement. Muscle tone of the ankle plantar flexors will be assessed in both knee flexion and extension. Hamstring spasticity will be tested in the supine position with the pelvic-femoral angle at 90°. After slow and fast stretching of the joint, two values of the angle will be measured according to angle R2 and R1 respectively. R1 is defined as the point in the PEHA at which a catch or clonus is first felt during rapid stretching of the joint, while R2 is defined as the total PEHA of the ankle. R2-R1 represents the dynamic component of spasticity. Spasticity will be measured according to the muscle reaction when stretching as fast as possible and will be graded from 0 to 5.
Measured: 5-10 minutes
Modified Ashworth Scale
Modified Ashworth Scale (MAS) will be used to evaluate muscle tone. Hamstring and plantar flexor muscle tone evaluation will begin in the supine position, with the head in the midline and the extremities in the resting position, and MAS scores will be determined between 0-4 according to the resistance level of the antagonist muscles during passive movement.
Measured: 5 minutes
Functional Reach Test
Functional Reach Test (FRT) will be used to measure trunk stability during reaching. The amount of lateral stretching will be measured from the tip of the 3rd metacarpal bone in a sitting position and at the edge of the wall.
Measured: 3 minutes
Trunk Impact Scale
Trunk Impact Scale (TIS) will be used to functionally evaluate the trunk in the sitting position. It has three subsections: static and dynamic sitting balance and coordination.
Measured: 5 minutes
Quality of Upper Extremity Skills Test
The Quality of Upper Extremity Skills Test (QUEST) will be used to evaluate the quality of upper extremity skills. The test is a criterion-referenced observational evaluation test consisting of 34 items. It consists of four subsections: "discrete movement", "grip", "weight transfer" and "protective extension". In the heterogeneous movements section of QUEST; The active joint movements of the child's upper extremity are observed one by one and scored according to the items. In the grip section; Functions such as grasping a cube, holding a pencil, grasping a chickpea are evaluated. In the weight transfer section, the child is asked to transfer weight to the front, side and back with his upper extremities while sitting. In the protective extension section, the protective extension reaction of the child forward, sideways and backward in response to a sudden push in a certain direction while the child is sitting is examined.
Measured: 10 minutes
Constipation Assessment Scale
The Constipation Assessment Scale (CAS) will be used to evaluate children's constipation status. This scale evaluates the presence and severity of constipation in children and adults. This scale, consisting of nine questions, is a valid and reliable tool.
Measured: 2 minutes
Functional Independence Measure for Children
Children's functional independence assessments The Functional Independence Measure for Children (WeeFIM) will be used. WeeFIM is a modified version of the Functional Independence Measure (FIM), which was developed for adults, for children. It consists of 6 subheadings, including self-care, sphincter control, transfer, movement, communication and social status, and a total of 18 questions. Scoring is made between 1-7, with a high score defining a good level of functional independence.
Measured: 3 minutes
Secondary outcomes (5)
Cerebral Palsy Quality of Life Questionnaire
The Cerebral Palsy Quality of Life Questionnaire will be used for health-related quality of life assessment. This questionnaire is a scale consisting of child and parent items in 7 areas such as "feelings about function", "participation and physical health".
Measured: 10 minutes
Selective Control Assessment of the Lower Extremity.
Selective Control Assessment of the Lower Extremity (SCALE) will be used to evaluate individuals' lower extremity selective motor control. It is a valid and reliable method in which selective control of lower extremity joint movements is scored between 0-2 points.
Measured: 5 minutes
Test of Arm Selective Control
Test of Arm Selective Control (TASC), developed by Sukal-Moulton et al. in 2017, was used to evaluate children's upper extremity selective motor control. Each movement was scored as 0 (absent), 1 (affected) or 2 (normal) according to descriptive subparameters.
Measured: 5 minutes
Drooling Impact Scale
he Drooling Impact Scale was completed by the same rater on two occasions, 1 month apart, to assess the impact of drooling in children who were expected to be stable. The scale has been shown to behave as expected in validity studies, to have good test-retest reliability in stable children, and to be responsive to change in children who have undergone saliva-control interventions
Measured: 3 minutes
Pittsburgh Sleep Quality Index
It is an index consisting of a total of 24 items that evaluate subsections such as sleep quality and duration.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start20 Jan 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mollii SuitStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Kübra Uğurlu, Gazi University
- Investigators
- Bülent Elbasan, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259864
- Sponsor's protocol ID
- CerebralPalyMolliiSuit
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pennati GV, Bergling H, Carment L, Borg J, Lindberg PG, Palmcrantz S. Effects of 60 Min Electrostimulation With the EXOPULSE Mollii Suit on Objective Signs of Spasticity. Front Neurol. 2021 Oct 15;12:706610. doi: 10.3389/fneur.2021.706610. eCollection 2021.
PubMed 34721255Flodstrom C, Viklund Axelsson SA, Nordstrom B. A pilot study of the impact of the electro-suit Mollii(R) on body functions, activity, and participation in children with cerebral palsy. Assist Technol. 2022 Jul 4;34(4):411-417. doi: 10.1080/10400435.2020.1837288. Epub 2021 Mar 29.
PubMed 33151822Perpetuini D, Russo EF, Cardone D, Palmieri R, De Giacomo A, Pellegrino R, Merla A, Calabro RS, Filoni S. Use and Effectiveness of Electrosuit in Neurological Disorders: A Systematic Review with Clinical Implications. Bioengineering (Basel). 2023 Jun 2;10(6):680. doi: 10.3390/bioengineering10060680.
PubMed 37370612Bakaniene I, Urbonaviciene G, Janaviciute K, Prasauskiene A. Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy. Neurol Neurochir Pol. 2018 Sep-Oct;52(5):581-586. doi: 10.1016/j.pjnns.2018.07.003. Epub 2018 Jul 20.
PubMed 30061001
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of Mollii Suit in Children With Non-Ambule Cerebral Palsy: A Single Blind Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06259864
- Acronym / sponsor ID
- CerebralPalyMolliiSuit
- Conditions
- Mollii Suit, Cerebral Palsy
- Keywords
- cerebral palsy, mollii suit, spasticity, salivation, constipation, gross motor function, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 14 Feb 2024 (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 aim of our study is to examine the effectiveness of the Mollii Suit application on gross motor function, spasticity, postural control, upper extremity skills, selective motor control, daily living activities, quality of life, pain, sleep, constipation and drooling problems in non-ambulatory individuals with cerebral palsy (CP).
Detailed description
Our study includes children diagnosed with spastic type cerebral palsy at GMFCS level 4 or 5 who applied to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.
After the patients are separated according to the specified exclusion and inclusion criteria, they will be divided into two groups by simple randomization method.
Evaluations will be made before and after treatment. In addition to normal neurodevelopmental therapy (NGT) and Mollii Suit method will be applied 2 days a week. The total duration of treatment will take 8 weeks. Groups; The first group will consist of children with CP who will receive neurodevelopmental treatment.
The second group will consist of children who will receive the Molli Suit method in addition to neurodevelopmental treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurodevelopmental treatment program group | Active comparator | Other: EXOPULSE Mollii Suit methodNDT aims to bring the child to the maximum level of independence possible within the limits of age and ability. Treatment sessions are planned for a certain functional result, and the patient's active participation as much as possible is requested. As the child fulfills postural and motor requirements, the physical therapist provides less assistance and less guidance. Positionings supported by auxiliary materials, appropriate hand contacts, correct ways to hold the child, tonus regulation, family education, environmental regulations and goal-oriented quality movement approaches; These are some of the methods used by the NDT approach, which is based on facilitation, stimulation and communication. Neurodevelopmental treatment physiotherapy session for 2 days in a week, over 8 week. |
| Mollii Suit method group | Experimental | Other: EXOPULSE Mollii Suit methodThe Exopulse Mollii Suit is designed to restore normality and healthy balance of muscle groups in the body. The suite uses one of several different forms of neuromodulation, based on gently stimulating the affected muscle groups with electrical signals. This approach has been shown to help resynchronize muscle signals that have been disrupted due to spasticity and muscle groups that may have stopped working together. 58 electrodes embedded in the suit send mild and imperceptible impulses to both tense and spastic muscles and the weakened muscles that balance them. These stimulations not only relax tense muscles and reactivate weak ones, but also restore the natural balance of the group and help the body move as it should. Children will wear the outfit twice a week for 8 weeks and each session will last 60 minutes. During this practice, children will also receive NDT twice a week. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- GMFCS 4 or 5 with spastic cerebral palsy children
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- Botulinum toxinA injection in the last 3 months
- Surgical intervention involving the musculoskeletal system in the last 6 months
- Having an invasive medical pump (baclofen, insulin, etc.)
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 |
|---|---|---|
| EXOPULSE Mollii Suit methodEXOPULSE Mollii Suit method, one of the newest rehabilitation technology products, is a non-invasive neuromodulation approach with a garment that covers the whole body and electrodes placed inside. Designed to improve motor function by reducing spasticity and pain, the method is based on the principle of reciprocal inhibition, which occurs by stimulating the antagonist of a spastic muscle at low frequencies and intensities. | Other | Mollii Suit method group, Neurodevelopmental treatment program group |
Primary outcome
Gross Motor Function Measure
Time frame: 15 minutes
GMFM evaluates children's motor activities in 5 different positions called 'lying down and rolling over', 'crawling and kneeling down', 'sitting', 'standing' and 'walking, running, jumping' on a scale of 0-3 (0: unable to initiate movement. 3: independent movement). It is a measurement method that scores.
Modified Tradiue Scale
Time frame: 5-10 minutes
Modified Tardiue Scale (MTS) will be used in the evaluation of spasticity. MTS is a method that evaluates the velocity-sensitive nature of spasticity through passive movement. Muscle tone of the ankle plantar flexors will be assessed in both knee flexion and extension. Hamstring spasticity will be tested in the supine position with the pelvic-femoral angle at 90°. After slow and fast stretching of the joint, two values of the angle will be measured according to angle R2 and R1 respectively. R1 is defined as the point in the PEHA at which a catch or clonus is first felt during rapid stretching of the joint, while R2 is defined as the total PEHA of the ankle. R2-R1 represents the dynamic component of spasticity. Spasticity will be measured according to the muscle reaction when stretching as fast as possible and will be graded from 0 to 5.
Modified Ashworth Scale
Time frame: 5 minutes
Modified Ashworth Scale (MAS) will be used to evaluate muscle tone. Hamstring and plantar flexor muscle tone evaluation will begin in the supine position, with the head in the midline and the extremities in the resting position, and MAS scores will be determined between 0-4 according to the resistance level of the antagonist muscles during passive movement.
Functional Reach Test
Time frame: 3 minutes
Functional Reach Test (FRT) will be used to measure trunk stability during reaching. The amount of lateral stretching will be measured from the tip of the 3rd metacarpal bone in a sitting position and at the edge of the wall.
Trunk Impact Scale
Time frame: 5 minutes
Trunk Impact Scale (TIS) will be used to functionally evaluate the trunk in the sitting position. It has three subsections: static and dynamic sitting balance and coordination.
Quality of Upper Extremity Skills Test
Time frame: 10 minutes
The Quality of Upper Extremity Skills Test (QUEST) will be used to evaluate the quality of upper extremity skills. The test is a criterion-referenced observational evaluation test consisting of 34 items. It consists of four subsections: "discrete movement", "grip", "weight transfer" and "protective extension". In the heterogeneous movements section of QUEST; The active joint movements of the child's upper extremity are observed one by one and scored according to the items. In the grip section; Functions such as grasping a cube, holding a pencil, grasping a chickpea are evaluated. In the weight transfer section, the child is asked to transfer weight to the front, side and back with his upper extremities while sitting. In the protective extension section, the protective extension reaction of the child forward, sideways and backward in response to a sudden push in a certain direction while the child is sitting is examined.
Constipation Assessment Scale
Time frame: 2 minutes
The Constipation Assessment Scale (CAS) will be used to evaluate children's constipation status. This scale evaluates the presence and severity of constipation in children and adults. This scale, consisting of nine questions, is a valid and reliable tool.
Functional Independence Measure for Children
Time frame: 3 minutes
Children's functional independence assessments The Functional Independence Measure for Children (WeeFIM) will be used. WeeFIM is a modified version of the Functional Independence Measure (FIM), which was developed for adults, for children. It consists of 6 subheadings, including self-care, sphincter control, transfer, movement, communication and social status, and a total of 18 questions. Scoring is made between 1-7, with a high score defining a good level of functional independence.
5 secondary outcomes
Cerebral Palsy Quality of Life Questionnaire
Time frame: 10 minutes
Selective Control Assessment of the Lower Extremity.
Time frame: 5 minutes
Test of Arm Selective Control
Time frame: 5 minutes
Drooling Impact Scale
Time frame: 3 minutes
Pittsburgh Sleep Quality Index
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Results publication: PubMed 34721255Pennati GV, Bergling H, Carment L, Borg J, Lindberg PG, Palmcrantz S. Effects of 60 Min Electrostimulation With the EXOPULSE Mollii Suit on Objective Signs of Spasticity. Front Neurol. 2021 Oct 15;12:706610. doi: 10.3389/fneur.2021.706610. eCollection 2021.
- Results publication: PubMed 33151822Flodstrom C, Viklund Axelsson SA, Nordstrom B. A pilot study of the impact of the electro-suit Mollii(R) on body functions, activity, and participation in children with cerebral palsy. Assist Technol. 2022 Jul 4;34(4):411-417. doi: 10.1080/10400435.2020.1837288. Epub 2021 Mar 29.
- Results publication: PubMed 37370612Perpetuini D, Russo EF, Cardone D, Palmieri R, De Giacomo A, Pellegrino R, Merla A, Calabro RS, Filoni S. Use and Effectiveness of Electrosuit in Neurological Disorders: A Systematic Review with Clinical Implications. Bioengineering (Basel). 2023 Jun 2;10(6):680. doi: 10.3390/bioengineering10060680.
- Results publication: PubMed 30061001Bakaniene I, Urbonaviciene G, Janaviciute K, Prasauskiene A. Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy. Neurol Neurochir Pol. 2018 Sep-Oct;52(5):581-586. doi: 10.1016/j.pjnns.2018.07.003. Epub 2018 Jul 20.
- Individual participant dataSharing planned: No
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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.
Bülent Elbasan contact
Bülent Elbasan study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXOPULSE Mollii Suit method in people with Mollii Suit and Cerebral Palsy, run by Kırıkkale University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Feb 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kübra Uğurlu (+905077295353, kubra.ozdamar06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure (time frame: 15 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06259864, which also lists 4 linked publications.
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 14 Feb 2024.