Imaging Data Collection From Dynamic Swallowing MRI in Healthy VolunteersSWALL-ENCT05178108
Transposition of Dynamic MRI Data From Healthy Subjects to an in Vitro Swallowing Simulator
A study testing Real-time MRI of swallowing in people with Imaging Data Collection From Dynamic Swallowing MRI in Healthy Volunteers and Create Operating Algorithms, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Swallowing is a complex process, involving a very fine synchronization of the pharyngo-larynx, with respiration, under the control of the central nervous system and numerous peripheral effectors. Any dysfunction can lead to aspiration a source of morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Imaging Data Collection From Dynamic Swallowing MRI in Healthy Volunteers, Create Operating Algorithms, Apply the Imaging Data of MRI to a Swallowing Simulator
- What is being tested?
- Real-time MRI of swallowing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2021to 27 Jul 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject, male or female, between 18 and 60 years of age, affiliated to a social health insurance scheme (beneficiary or beneficiary's assistant)
- Subject able to understand the objectives and risks of the research and to give a dated and signed informed consent
- Subject has been informed of the results of the prior medical examination
- Healthy subject with no clinical swallowing disorders
- For a woman of childbearing age, negative urine pregnancy test at the inclusion visit
Who cannot join
- Subject with a contraindication to MRI: presence of non-removable ferromagnetic body, pacemaker, medication delivered by an implanted pump, ventricular bypass, history of epilepsy
- Subjects allergic to pineapple or latex
- Claustrophobic subject
- Subject suffering from swallowing disorders
- Subject with galactosemia
- Subject with dysphonia/dysphagia or inspiratory dyspnea on physical examination
Show all 16Show fewer
- Subject with a history of cervico-facial surgery and/or radiotherapy
- Subject with a history of malignant or benign cervicofacial lesion
- Subject who has undergone intubation or endoscopy of the upper aerodigestive tract in the 3 months preceding the MRI
- Subject suffering from a degenerative neurological pathology
- Subject suffering from cardiac or respiratory insufficiency
- Subject in an exclusion period (as determined by a previous or current study)
- Unable to provide subject with informed information (subject in emergency situation, difficulty understanding subject)
- Pregnancy and/or breastfeeding
- Subject under court protection
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'ORL Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
About this study
Official title: Transposition of Dynamic MRI Data From Healthy Patients to an in Vitro Swallowing Simulator
Swallowing is a complex process, involving a very fine synchronization of the pharyngo-larynx, with respiration, under the control of the central nervous system and numerous peripheral effectors. Any dysfunction can lead to aspiration a source of morbidity and mortality.
These dysfunctions of the aerodigestive tract affect a considerable number of patients with multiple etiologies: squamous cell carcinoma of the upper aerodigestive tract, peripheral or central neurological dysfunctions, neurosurgical or neurovascular causes, geriatric pathologies and intensive care complications.
Read more
Aspiration pneumopathy is the most severe complication, which can lead to death. For decades, only techniques such as tracheotomy or enteral feeding (nasogastric tube/gastrostomy tube), associated or not with speech therapy, have been proposed to counter this problem. These invasive treatments remain symptomatic. These treatments bypass the pharyngolaryngeal dysfunction without resolving it and still significantly alter the patients' quality of life.
In 2012, a first worldwide clinical study (published in the NEJM) based on 6 patients, conducted by the ENT team in Strasbourg, demonstrated an improvement in the quality of life of patients who had undergone total laryngectomy, by proposing the placement of a titanium laryngeal implant equipped with an upper valve. This strategy intended to avoid aspiration of food hile allowing normal breathing. Although this technique did not solve all problems (the persistence of food going the wrong way), this study allowed a conceptual change in the attempt to solve swallowing problems by the introduction of pharyngolaryngeal implants.
The latter remains a challenge, but clinical trials of implants with a functional valve effected after removal of the larynx or on an existing but dysfunctional larynx have demonstrated the indivisibility of the pharynx-larynx couple in the search for permanent solutions.
This physiological process can be studied with imaging. Videofluoroscopy is the reference method allowing a dynamic study of swallowing. However, it does not allow the study of soft tissue movement and exposes the patient to repeated irradiation. Recently, MRI has shown its ability to visualize the entire pharyngolaryngeal structures accurately and dynamically during the swallowing process.
To improve the understanding and resolution of swallowing disorders, a unique robotic platform, consisting of a dynamic silicone skeleton reproducing the complexity of the pharyngolarynx, was initially developed by PROTIP MEDICAL (SWALL-E). This is the object of a French patent, transferred to the HUS University Hospitals of Strasbourg.
The aim this study is to correlate and calibrate this platform with dynamic MRI data in healthy subjects, by studying the movement of the different anatomical structures of the pharyngolarynx during swallowing movements (speed, amplitude and synchronization of the pharyngolarynx movements).
The immediate application of SWALL-E, after calibration and validation, will: i) allow the reproduction of a physiological swallowing mechanism; ii) allow to produce a pathological and personalized simulation of swallowing disorders in vitro; iii) allow the design of implants produced by 3D printing, and to analyze their effectiveness before implantation; iv) to modify in parallel and if necessary the rheology of the food boluses, thus contributing to a significant global improvement for the patient.
Thus, this platform, unique in its conception, aims not only at making a diagnosis of the specific pathology of the patient, but also aims at a personalized management adapted to the patient, inexistent until now.
Indeed, if the diagnostic methods are numerous (nasofibroscopy, swallowing transit, videofluoroscopy, study of swallowing noises by acoustic signals, swallowing cinetigraphy...), the treatments have remained identical for decades (speech therapy), and are not targeted (pharyngeal stimulation), despite the fact that each patient presents a specific pathology that is difficult to reunify under a "universal" treatment.
Read the detailed description
To date, in vitro models of the pharyngeal phase of swallowing have led to limited results. No high-fidelity robot of the pharyngo-larynx has been developed.
For this purpose, a robotic device, called SWALL-E (21) was created. It is based on a realistic anatomical model of a human pharyngolaryngeal tract in which the anatomical structures and mechanisms involved in the pharyngeal swallowing phase are precisely actuated and controlled. It allows to simulate a swallow in terms of dynamics, size, and timing by reproducing the anatomical structures directly involved in the bolus transport process of the pharyngeal phase (tongue base retraction; vocal cords opening/closing; larynx elevation; pharynx contraction; epiglottis tilt; upper esophageal sphincter opening/closing). SWALL-E, illustrated below, was designed with the main goal of reproducing with maximum fidelity the anatomy and physiology of the pharyngeal phase of adult human swallowing The SWALL-E platform is currently operational but has not yet been calibrated.
The specifications were defined as follows: i) full-scale model of the adult human anatomical tract in a flexible material; ii) reproduction of the anatomical structures directly involved in the bolus transport process of the pharyngeal phase; iii) reproduction of the critical physiological mechanisms in an accurate and spatially and temporally adjustable manner.
The mechanisms reproduced are i) bolus injection; ii) tongue base retraction; iii) vocal cord opening/closing; iv) laryngeal elevation; v) pharyngeal contraction; vi) epiglottis tilt; vii) upper esophageal sphincter opening/closing.
The normal swallowing sequences performed demonstrated the ability of the system to reproduce the chronological order of biomechanical movements. This was achieved from clinical observations, and then adapted into a model whereby the movement and path of the food bolus can be physically imitated and controlled.
SWALL-E is thus able to simulate the in vitro pharyngolaryngeal phase of "normal" swallowing by achieving a transit time comparable to that found in a healthy subject without any misdirection.
The current SWALL-E kinetics were adjusted via subjectively obtained parameterizations by empirical observation of experienced clinicians (ENT) at nasofibroscopy. The dynamic MRI of swallowing will provide quantitative data on the velocities and amplitudes of the movements of the different anatomical structures present within SWALL-E: tongue base, epiglottis, pharyngeal constructor muscles, vocal cords and upper esophageal sphincter.
Transposing the data collected via MRI will allow to improve the accuracy and coordination of the kinetics of the synthetically reproduced movements.
Furthermore, by transposing the MRI data to SWALL-E, the investigators will be able to synchronize SWALL-E with data collected from any swallowing MRI performed in patients.
To improve SWALL-E, it will be necessary to exploit objective numerical data: speed and amplitude of movement of the anatomical structures of the pharyngo-larynx, measured by swallowing MRIs. These numerical data will make it possible to create a typical parameterization to obtain a functioning of the device as close as possible to a "normal" (healthy) pharyngolaryngeal set. Once the "normal swallowing" settings are achieved, it will be possible to mimic different types of "pathological swallowing".
The SWALL-E swallowing simulator (anatomical duct and simulation bench including such a duct) was the object of a national patent registration in 2017 (with a supplement in 2018), under the reference FR3071347A1, transferred to the University Hospitals of Strasbourg.
Swall-E is controlled by Lab-Viex software but the data acquired at imaging will be processed on a video tracking software (APREX track-R\&D) to then be transposed to SWALL-E.
- Conditions
- Imaging Data Collection From Dynamic Swallowing MRI in Healthy Volunteers, Create Operating Algorithms, Apply the Imaging Data of MRI to a Swallowing Simulator
- Being tested
- Real-time MRI of swallowing
- Keywords
- dysphagia, deglutition in normal subjects, swallowing, robotic in-vitro simulation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time MRI of swallowingOther
The examination recording a total of 9 sequences of less than 30 seconds will be performed, in transverse section (passing through the epiglottis), frontal section, in the plane of the posterior pharyngeal wall, and in median sagittal section.
Each bolus of 20 ml will be administered in full, in one go, using a syringe. It is kept in the mouth for a few seconds and swallowed on demand.
The semi-liquid bolus of 20 ml comes from the mixture of 198 ml of pineapple juice to 10 gr of Nutilis Powder (NUTRICIA), food thickener containing neither gluten, nor lactose.
Ingredients: Dextrin-maltose, thickeners (modified starch (corn), tara gum, xanthan gum, guar gum).
- 3 sequences with no food
- 3 sequences with ingestion of a liquid bolus of 20 ml (pineapple juice) mouth closed
- 3 sequences with ingestion of a semi-liquid bolus of 20 ml (pineapple juice + Nutilis Powder) mouth closed
| Study group | Role | What they receive |
|---|---|---|
| healthy individuals | Other | Not described Receives: Other: Real-time MRI of swallowing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Collect dynamic swallowing MRI imaging data from healthy volunteers
to process to define the anatomical structures of interest
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start26 Oct 2021
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Imaging Data Collection From Dynamic Swallowing MRI in Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178108
- Sponsor's protocol ID
- 8260
- Acronym
- SWALL-E
- Status last verified
- Jan 2023
- First submitted
- 22 Oct 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transposition of Dynamic MRI Data From Healthy Patients to an in Vitro Swallowing Simulator
- ClinicalTrials.gov ID
- NCT05178108
- Acronym / sponsor ID
- SWALL-E / 8260
- Conditions
- Imaging Data Collection From Dynamic Swallowing MRI in Healthy Volunteers, Create Operating Algorithms, Apply the Imaging Data of MRI to a Swallowing Simulator
- Keywords
- dysphagia, deglutition in normal subjects, swallowing, robotic in-vitro simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 5 Jan 2022 (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.
Swallowing is a complex process, involving a very fine synchronization of the pharyngo-larynx, with respiration, under the control of the central nervous system and numerous peripheral effectors. Any dysfunction can lead to aspiration a source of morbidity and mortality.
These dysfunctions of the aerodigestive tract affect a considerable number of patients with multiple etiologies: squamous cell carcinoma of the upper aerodigestive tract, peripheral or central neurological dysfunctions, neurosurgical or neurovascular causes, geriatric pathologies and intensive care complications.
Aspiration pneumopathy is the most severe complication, which can lead to death. For decades, only techniques such as tracheotomy or enteral feeding (nasogastric tube/gastrostomy tube), associated or not with speech therapy, have been proposed to counter this problem. These invasive treatments remain symptomatic. These treatments bypass the pharyngolaryngeal dysfunction without resolving it and still significantly alter the patients' quality of life.
In 2012, a first worldwide clinical study (published in the NEJM) based on 6 patients, conducted by the ENT team in Strasbourg, demonstrated an improvement in the quality of life of patients who had undergone total laryngectomy, by proposing the placement of a titanium laryngeal implant equipped with an upper valve. This strategy intended to avoid aspiration of food hile allowing normal breathing. Although this technique did not solve all problems (the persistence of food going the wrong way), this study allowed a conceptual change in the attempt to solve swallowing problems by the introduction of pharyngolaryngeal implants.
The latter remains a challenge, but clinical trials of implants with a functional valve effected after removal of the larynx or on an existing but dysfunctional larynx have demonstrated the indivisibility of the pharynx-larynx couple in the search for permanent solutions.
This physiological process can be studied with imaging. Videofluoroscopy is the reference method allowing a dynamic study of swallowing. However, it does not allow the study of soft tissue movement and exposes the patient to repeated irradiation. Recently, MRI has shown its ability to visualize the entire pharyngolaryngeal structures accurately and dynamically during the swallowing process.
To improve the understanding and resolution of swallowing disorders, a unique robotic platform, consisting of a dynamic silicone skeleton reproducing the complexity of the pharyngolarynx, was initially developed by PROTIP MEDICAL (SWALL-E). This is the object of a French patent, transferred to the HUS University Hospitals of Strasbourg.
The aim this study is to correlate and calibrate this platform with dynamic MRI data in healthy subjects, by studying the movement of the different anatomical structures of the pharyngolarynx during swallowing movements (speed, amplitude and synchronization of the pharyngolarynx movements).
The immediate application of SWALL-E, after calibration and validation, will: i) allow the reproduction of a physiological swallowing mechanism; ii) allow to produce a pathological and personalized simulation of swallowing disorders in vitro; iii) allow the design of implants produced by 3D printing, and to analyze their effectiveness before implantation; iv) to modify in parallel and if necessary the rheology of the food boluses, thus contributing to a significant global improvement for the patient.
Thus, this platform, unique in its conception, aims not only at making a diagnosis of the specific pathology of the patient, but also aims at a personalized management adapted to the patient, inexistent until now.
Indeed, if the diagnostic methods are numerous (nasofibroscopy, swallowing transit, videofluoroscopy, study of swallowing noises by acoustic signals, swallowing cinetigraphy...), the treatments have remained identical for decades (speech therapy), and are not targeted (pharyngeal stimulation), despite the fact that each patient presents a specific pathology that is difficult to reunify under a "universal" treatment.
Detailed description
To date, in vitro models of the pharyngeal phase of swallowing have led to limited results. No high-fidelity robot of the pharyngo-larynx has been developed.
For this purpose, a robotic device, called SWALL-E (21) was created. It is based on a realistic anatomical model of a human pharyngolaryngeal tract in which the anatomical structures and mechanisms involved in the pharyngeal swallowing phase are precisely actuated and controlled. It allows to simulate a swallow in terms of dynamics, size, and timing by reproducing the anatomical structures directly involved in the bolus transport process of the pharyngeal phase (tongue base retraction; vocal cords opening/closing; larynx elevation; pharynx contraction; epiglottis tilt; upper esophageal sphincter opening/closing). SWALL-E, illustrated below, was designed with the main goal of reproducing with maximum fidelity the anatomy and physiology of the pharyngeal phase of adult human swallowing The SWALL-E platform is currently operational but has not yet been calibrated.
The specifications were defined as follows: i) full-scale model of the adult human anatomical tract in a flexible material; ii) reproduction of the anatomical structures directly involved in the bolus transport process of the pharyngeal phase; iii) reproduction of the critical physiological mechanisms in an accurate and spatially and temporally adjustable manner.
The mechanisms reproduced are i) bolus injection; ii) tongue base retraction; iii) vocal cord opening/closing; iv) laryngeal elevation; v) pharyngeal contraction; vi) epiglottis tilt; vii) upper esophageal sphincter opening/closing.
The normal swallowing sequences performed demonstrated the ability of the system to reproduce the chronological order of biomechanical movements. This was achieved from clinical observations, and then adapted into a model whereby the movement and path of the food bolus can be physically imitated and controlled.
SWALL-E is thus able to simulate the in vitro pharyngolaryngeal phase of "normal" swallowing by achieving a transit time comparable to that found in a healthy subject without any misdirection.
The current SWALL-E kinetics were adjusted via subjectively obtained parameterizations by empirical observation of experienced clinicians (ENT) at nasofibroscopy. The dynamic MRI of swallowing will provide quantitative data on the velocities and amplitudes of the movements of the different anatomical structures present within SWALL-E: tongue base, epiglottis, pharyngeal constructor muscles, vocal cords and upper esophageal sphincter.
Transposing the data collected via MRI will allow to improve the accuracy and coordination of the kinetics of the synthetically reproduced movements.
Furthermore, by transposing the MRI data to SWALL-E, the investigators will be able to synchronize SWALL-E with data collected from any swallowing MRI performed in patients.
To improve SWALL-E, it will be necessary to exploit objective numerical data: speed and amplitude of movement of the anatomical structures of the pharyngo-larynx, measured by swallowing MRIs. These numerical data will make it possible to create a typical parameterization to obtain a functioning of the device as close as possible to a "normal" (healthy) pharyngolaryngeal set. Once the "normal swallowing" settings are achieved, it will be possible to mimic different types of "pathological swallowing".
The SWALL-E swallowing simulator (anatomical duct and simulation bench including such a duct) was the object of a national patent registration in 2017 (with a supplement in 2018), under the reference FR3071347A1, transferred to the University Hospitals of Strasbourg.
Swall-E is controlled by Lab-Viex software but the data acquired at imaging will be processed on a video tracking software (APREX track-R\&D) to then be transposed to SWALL-E.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy individuals | Other | Other: Real-time MRI of swallowing |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject, male or female, between 18 and 60 years of age, affiliated to a social health insurance scheme (beneficiary or beneficiary's assistant)
- Subject able to understand the objectives and risks of the research and to give a dated and signed informed consent
- Subject has been informed of the results of the prior medical examination
- Healthy subject with no clinical swallowing disorders
- For a woman of childbearing age, negative urine pregnancy test at the inclusion visit
Key exclusion criteria (16 listed)
- Subject with a contraindication to MRI: presence of non-removable ferromagnetic body, pacemaker, medication delivered by an implanted pump, ventricular bypass, history of epilepsy
- Subjects allergic to pineapple or latex
- Claustrophobic subject
- Subject suffering from swallowing disorders
- Subject with galactosemia
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 |
|---|---|---|
| Real-time MRI of swallowingThe examination recording a total of 9 sequences of less than 30 seconds will be performed, in transverse section (passing through the epiglottis), frontal section, in the plane of the posterior pharyngeal wall, and in median sagittal section. Each bolus of 20 ml will be administered in full, in one go, using a syringe. It is kept in the mouth for a few seconds and swallowed on demand. The semi-liquid bolus of 20 ml comes from the mixture of 198 ml of pineapple juice to 10 gr of Nutilis Powder (NUTRICIA), food thickener containing neither gluten, nor lactose. Ingredients: Dextrin-maltose, thickeners (modified starch (corn), tara gum, xanthan gum, guar gum). * 3 sequences with no food * 3 sequences with ingestion of a liquid bolus of 20 ml (pineapple juice) mouth closed * 3 sequences with ingestion of a semi-liquid bolus of 20 ml (pineapple juice + Nutilis Powder) mouth closed | Other | healthy individuals |
Primary outcome
To Collect dynamic swallowing MRI imaging data from healthy volunteers
Time frame: 1 hour
to process to define the anatomical structures of interest
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 1 Feb 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time MRI of swallowing in people with Imaging Data Collection From Dynamic Swallowing MRI in Healthy Volunteers and Create Operating Algorithms, run by University Hospital, Strasbourg, France 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 5 inclusion and 16 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 1 Feb 2023. 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?
To Collect dynamic swallowing MRI imaging data from healthy volunteers (time frame: 1 hour). 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 1 Feb 2023.