Anorexia Nervosa (DSM-IV Revised Criteria)Phase 1NCT07113665
Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for Refractory Anorexia Nervosa With Comorbid Obsessive Compulsive Disorder or Major Depressive Disorder
A Phase 1 study testing ExAblate Neuro 4000 in people with Anorexia Nervosa (DSM-IV Revised Criteria), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The goal of this clinical trial is to evaluate the safety and initial clinical effectiveness of MRI-guided focused ultrasound (MRgFUS) thermal ablation (capsulotomy) in patients with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anorexia Nervosa (DSM-IV Revised Criteria)
- What is being tested?
- ExAblate Neuro 4000
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2025to Aug 2028
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥18 and ≤65 years of age, inclusive.
- Patients who are competent and willing to give consent and able to attend study visits, as determined by both study Psychiatrist and the surgeon.
- DSM-V diagnosis of Anorexia Nervosa, with co-morbid diagnosis of OCD and/or Major depressive disorder.
- Treatment refractoriness indicated by any of:
- Duration of illness more than 10 years with no more than three months of remission in terms of weight;
- At least three attempts at expert hospital based treatment that were not successful or where there was no sustained response to treatment;
- A pattern of increased medical instability requiring at least two episodes of emergency/involuntary re-feeding and lasting at least two years;
- Ability to provide informed consent/competent to make medical decisions.
Who cannot join
- Patients with unstable cardiac status [e.g. Unstable angina pectoris on medication, Patients with documented myocardial infarction within six months, Congestive heart failure requiring medication (other than diuretic), Patients on anti-arrhythmic drugs, Severe hypertension (diastolic BP > 100 on medication)]
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy, including risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter or abnormal INR)
- Cerebrovascular disease (e.g. CVA within 6 months) or history of intracranial hemorrhage
- Untreated, uncontrolled sleep apnea
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
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- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- Are participating or have participated in another clinical trial in the last 30 days
- Patients unable to communicate with the investigator and staff.
- Presence of significant cognitive impairment
- History of psychosis on clinical evaluation.
- Patients with brain tumors already known or revealed on pretreatment MRI
- Currently pregnant (as determined by history and serum HCG) or lactating.
- Chemical abuse or dependence within the previous six months
- Presence of a metabolic pathology interfering with eating or digestion (e.g. diabetes).
- Body mass index (BMI) less than 13
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Anusha Baskaran, PhD, 416-480-6100 ext. 61650, anusha.baskaran@sunnybrook.ca
About this study
Official title: Phase I Trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Anorexia Nervosa With Co-morbid Obsessive Compulsive Disorder or Major Depressive Disorder
The goal of this clinical trial is to evaluate the safety and initial clinical effectiveness of MRI-guided focused ultrasound (MRgFUS) thermal ablation (capsulotomy) in patients with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and major depressive disorder (MDD). The main questions it aims to answer are:
- Can MR-guided focused ultrasound capsulotomy be safely delivered through an intact skull in patients with treatment-refractory anorexia nervosa and comorbid OCD and/or MDD, with a safety and side-effect profile comparable to traditional radiofrequency neurosurgical approaches?
- Does MRgFUS capsulotomy produce clinical outcomes comparable to open surgical ablative procedures-specifically, improvements in anxiety, mood, quality of life, anorexia nervosa psychopathology, habit formation, and weight-in patients with treatment-refractory anorexia nervosa?
Read more
Participants will:
- Undergo baseline imaging and clinical assessments
- Receive a single MRgFUS capsulotomy targeting the ALIC
- Be monitored for 24 months post-treatment to assess adverse events, quality of life, and symptom changes using standardized clinical and neuropsychiatric measures
Read the detailed description
This is a single-centre, prospective, single-arm, non-randomized Phase I study evaluating the safety, feasibility, and preliminary clinical benefit of MRI-guided focused ultrasound (MRgFUS) for the treatment of treatment-refractory anorexia nervosa (AN) with comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD).
A total of 10 patients will be enrolled and treated with a single MRgFUS capsulotomy targeting the anterior limb of the internal capsule (ALIC).
Participants will undergo comprehensive pre-treatment evaluations, including psychiatric assessment, physical and nutritional status review, MRI imaging, and surgical eligibility screening. The treatment will be performed using the ExAblate 4000 system under continuous MRI guidance and real-time thermometry.
Participants will be followed at regular intervals, including immediately post-treatment and at 1, 3, 6, 12, 18, and 24 months post-procedure, to evaluate safety and changes in clinical symptoms.
- Being tested
- ExAblate Neuro 4000
- Keywords
- Anorexia Nervosa, MR-guided Focused Ultrasound, bilateral capsulotomy, Obsessive Compulsive Disorder, Major Depressive Disorder
- Medical subject headings
- Anorexia Nervosa, Obsessive-Compulsive Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate Neuro 4000Device
The ExAblate Neuro 4000 is an MRI-guided focused ultrasound (MRgFUS) system designed to perform noninvasive thermal ablation of targeted brain tissue. In this study, the ExAblate Neuro 4000 will be used to perform a bilateral capsulotomy by ablating the anterior limb of the internal capsule (ALIC) in patients with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD). The procedure will be conducted under real-time MRI guidance and thermometry to ensure accurate targeting and controlled thermal delivery. This study aims to evaluate the safety, feasibility, and preliminary clinical benefit of MRgFUS in improving psychiatric symptoms and quality of life in this patient population.
| Study group | Role | What they receive |
|---|---|---|
| MR- guided Focused Ultrasound Capsulotomy | Experimental | Participants in this arm will undergo a single MRI-guided focused ultrasound (MRgFUS) thermal ablation procedure targeting the anterior limb of the internal capsule (ALIC). The procedure is performed using the ExAblate 4000 MRgFUS system, with real-time MR thermometry to ensure precise lesioning.
This intervention is intended for individuals with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD) who meet surgical eligibility criteria. All participants will complete standardized psychiatric and quality of life assessments at baseline and follow-up time points up to 24 months post-treatment to evaluate safety, feasibility, and preliminary clinical efficacy. Receives: Device: ExAblate Neuro 4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Feasibility of MRgFUS Capsulotomy in Patients with Treatment-Refractory Anorexia Nervosa
The frequency and severity of adverse events associated with ExAblate Transcranial Magnetic Resonance-guided Focused Ultrasound (MRgFUS) will be evaluated in patients with treatment-refractory anorexia nervosa and comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD). All adverse events-including procedure-related complications, neurological events, and other safety concerns-will be systematically documented, monitored, and assessed throughout the study duration.
Measured: From day of treatment through 24 months post-treatment with evaluations at immediate post-op, 1, 3, 6, 12, 18 and 24 months.
Secondary outcomes (6)
Change in Body Mass Index Following MRgFUS Capsulotomy
Body Mass Index (BMI) will be used as an objective indicator of weight change and nutritional status. BMI will be calculated using weight (kg) divided by height (m²). Participants' BMI will be tracked over time to evaluate whether MRgFUS targeting the anterior limb of the internal capsule (ALIC) is associated with weight stabilization or improvement in individuals with treatment-refractory anorexia nervosa.
Recommended BMI (Body Mass Index) for most adults is generally:
Underweight: Below 18.5 Normal/Healthy weight: 18.5 - 24.9 Overweight: 25.0 - 29.9 Obese: 30.0 and above
Notes:
- The above mentioned ranges are from the World Health Organization (WHO) and are intended for adults 18-65 years old.
- BMI is a quick screening tool but doesn't account for muscle mass, bone density, age or gender.
Measured: Assessments will be conducted at baseline, 1, 3, 6, 12, 18, and 24 months following the procedure.
Change in Depressive Symptoms Using the Beck Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item self-report inventory assessing the presence and severity of depressive symptoms. Each item is scored from 0 to 3, with a total score range of 0 to 63. Higher scores reflect more severe depressive symptoms.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
Change in Anxiety Symptoms Using the Beck Anxiety Inventory
Evaluate the effectiveness of MR-guided Focused Ultrasound (MRgFUS) in reducing anxiety symptom severity using the Beck Anxiety Inventory (BAI), a validated patient-reported scale. Assessments will occur at baseline and at specified follow-up visits. The BAI consists of 21 items measuring common symptoms of anxiety experienced over the past week. Each item is rated on a scale from 0 (not at all) to 3 (severely). Total scores range from 0 to 63, with higher scores indicating more severe anxiety symptoms
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
Change in Quality of Life Using the Quality of Life Enjoyment and Satisfaction Questionnaire
The Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ-SF) is a 14-item self-report questionnaire evaluating life satisfaction across various domains (e.g., physical health, mood, work, social life). Items are scored from 1 (very poor) to 5 (very good) and converted to a percentage (0-100%).
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
Change in Obsessive-Compulsive Symptoms Using the Obsessive Compulsive Inventory
Obsessive Compulsive Inventory (OCI) - The Obsessive Compulsive Inventory is a self-report questionnaire used to assess the severity of obsessive-compulsive symptoms across six domains: washing, checking, ordering, obsessing, hoarding, and mental neutralizing. It consists of items scored from 0 (not at all) to 4 (extremely), with total scores ranging from 0 (no symptoms) to 72 (most severe symptoms). Higher scores indicate a worse outcome (greater severity of obsessive-compulsive symptoms).
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
Change in Suicide Risk Using the Columbia-Suicide Severity Rating Scale
Columbia-Suicide Severity Rating Scale (C-SSRS) - The Columbia-Suicide Severity Rating Scale is a clinician-administered tool that evaluates suicidal ideation and behavior, including the severity and intensity of thoughts and the presence of actual, interrupted, or aborted suicide attempts. Scores range from 0 (no suicidal ideation or behavior) to 25 (most severe), with higher scores indicating a worse outcome (greater suicidal risk).
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia Nervosa (DSM-IV Revised Criteria)Studies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nir Lipsman, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113665
- Sponsor's protocol ID
- 6590
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Anorexia Nervosa With Co-morbid Obsessive Compulsive Disorder or Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07113665
- Acronym / sponsor ID
- 6590
- Keywords
- Anorexia Nervosa, MR-guided Focused Ultrasound, bilateral capsulotomy, Obsessive Compulsive Disorder, Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 11 Aug 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 goal of this clinical trial is to evaluate the safety and initial clinical effectiveness of MRI-guided focused ultrasound (MRgFUS) thermal ablation (capsulotomy) in patients with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and major depressive disorder (MDD). The main questions it aims to answer are:
- Can MR-guided focused ultrasound capsulotomy be safely delivered through an intact skull in patients with treatment-refractory anorexia nervosa and comorbid OCD and/or MDD, with a safety and side-effect profile comparable to traditional radiofrequency neurosurgical approaches?
- Does MRgFUS capsulotomy produce clinical outcomes comparable to open surgical ablative procedures-specifically, improvements in anxiety, mood, quality of life, anorexia nervosa psychopathology, habit formation, and weight-in patients with treatment-refractory anorexia nervosa?
Participants will:
- Undergo baseline imaging and clinical assessments
- Receive a single MRgFUS capsulotomy targeting the ALIC
- Be monitored for 24 months post-treatment to assess adverse events, quality of life, and symptom changes using standardized clinical and neuropsychiatric measures
Detailed description
This is a single-centre, prospective, single-arm, non-randomized Phase I study evaluating the safety, feasibility, and preliminary clinical benefit of MRI-guided focused ultrasound (MRgFUS) for the treatment of treatment-refractory anorexia nervosa (AN) with comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD).
A total of 10 patients will be enrolled and treated with a single MRgFUS capsulotomy targeting the anterior limb of the internal capsule (ALIC).
Participants will undergo comprehensive pre-treatment evaluations, including psychiatric assessment, physical and nutritional status review, MRI imaging, and surgical eligibility screening. The treatment will be performed using the ExAblate 4000 system under continuous MRI guidance and real-time thermometry.
Participants will be followed at regular intervals, including immediately post-treatment and at 1, 3, 6, 12, 18, and 24 months post-procedure, to evaluate safety and changes in clinical symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR- guided Focused Ultrasound Capsulotomy | Experimental | Device: ExAblate Neuro 4000Participants in this arm will undergo a single MRI-guided focused ultrasound (MRgFUS) thermal ablation procedure targeting the anterior limb of the internal capsule (ALIC). The procedure is performed using the ExAblate 4000 MRgFUS system, with real-time MR thermometry to ensure precise lesioning. This intervention is intended for individuals with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD) who meet surgical eligibility criteria. All participants will complete standardized psychiatric and quality of life assessments at baseline and follow-up time points up to 24 months post-treatment to evaluate safety, feasibility, and preliminary clinical efficacy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women ≥18 and ≤65 years of age, inclusive.
- Patients who are competent and willing to give consent and able to attend study visits, as determined by both study Psychiatrist and the surgeon.
- DSM-V diagnosis of Anorexia Nervosa, with co-morbid diagnosis of OCD and/or Major depressive disorder.
- Treatment refractoriness indicated by any of:
- Ability to provide informed consent/competent to make medical decisions.
Key exclusion criteria (16 listed)
- Patients with unstable cardiac status [e.g. Unstable angina pectoris on medication, Patients with documented myocardial infarction within six months, Congestive heart failure requiring medication (other than diuretic), Patients on anti-arrhythmic drugs, Severe hypertension (diastolic BP > 100 on medication)]
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy, including risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter or abnormal INR)
- Cerebrovascular disease (e.g. CVA within 6 months) or history of intracranial hemorrhage
- Untreated, uncontrolled sleep apnea
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 |
|---|---|---|
| ExAblate Neuro 4000The ExAblate Neuro 4000 is an MRI-guided focused ultrasound (MRgFUS) system designed to perform noninvasive thermal ablation of targeted brain tissue. In this study, the ExAblate Neuro 4000 will be used to perform a bilateral capsulotomy by ablating the anterior limb of the internal capsule (ALIC) in patients with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD). The procedure will be conducted under real-time MRI guidance and thermometry to ensure accurate targeting and controlled thermal delivery. This study aims to evaluate the safety, feasibility, and preliminary clinical benefit of MRgFUS in improving psychiatric symptoms and quality of life in this patient population. | Device | MR- guided Focused Ultrasound Capsulotomy |
Primary outcome
Safety and Feasibility of MRgFUS Capsulotomy in Patients with Treatment-Refractory Anorexia Nervosa
Time frame: From day of treatment through 24 months post-treatment with evaluations at immediate post-op, 1, 3, 6, 12, 18 and 24 months.
The frequency and severity of adverse events associated with ExAblate Transcranial Magnetic Resonance-guided Focused Ultrasound (MRgFUS) will be evaluated in patients with treatment-refractory anorexia nervosa and comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD). All adverse events-including procedure-related complications, neurological events, and other safety concerns-will be systematically documented, monitored, and assessed throughout the study duration.
6 secondary outcomes
Change in Body Mass Index Following MRgFUS Capsulotomy
Time frame: Assessments will be conducted at baseline, 1, 3, 6, 12, 18, and 24 months following the procedure.
Change in Depressive Symptoms Using the Beck Depression Inventory
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
Change in Anxiety Symptoms Using the Beck Anxiety Inventory
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
Change in Quality of Life Using the Quality of Life Enjoyment and Satisfaction Questionnaire
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
Change in Obsessive-Compulsive Symptoms Using the Obsessive Compulsive Inventory
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
Change in Suicide Risk Using the Columbia-Suicide Severity Rating Scale
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post-treatment.
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 14 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ExAblate Neuro 4000 in people with Anorexia Nervosa (DSM-IV Revised Criteria), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 8 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: looking for participants now, as of the sponsor's last update on 14 Aug 2025. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nir Lipsman, MD, PhD, FRCSC (416-480-6954, Nir.Lipsman@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Feasibility of MRgFUS Capsulotomy in Patients with Treatment-Refractory Anorexia Nervosa (time frame: From day of treatment through 24 months post-treatment with evaluations at immediate post-op, 1, 3, 6, 12, 18 and 24 months.). 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 14 Aug 2025.