Glioblastoma MultiformeNCT04446416

Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients

A study testing NaviFUS System and Bevacizumab in people with Glioblastoma Multiforme and Glioblastoma, run by NaviFUS Corporation at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a prospective, single-arm, two stages, open-label, pilot study to investigate the efficacy and safety of FUS add-on bevacizumab (BEV) in rGBM patients. The BEV is the best physician's choice of standard of care for rGBM after prior radiotherapy and temozolomide chemotherapy in the LinKou Chang Gung Memorial… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Glioblastoma Multiforme, Glioblastoma, Glioma
What is being tested?: NaviFUS System and Bevacizumab
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteTaiwan
Study dates: 21 Jul 2020to 4 Aug 2023
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult male/female patients ≥ 20 years of age
Patients with histologically confirmed glioblastoma, recurrent after prior radiotherapy and temozolomide chemotherapy.
Patient may have been operated for recurrence. If operated: with measurable residual tumor
Minimum interval since completion of radiation treatment is 12 weeks
Patients if already on the steroids then should be on a stable dose of steroids for at least 7 days prior to study treatment
Body mass index (BMI) ≥17 kg / m2

Show all 27Show fewer

Minimum interval since last drug therapy:
1 week for non-cytotoxic agents (e.g., interferon, tamoxifen), daily chemotherapy (e.g., metronomic temozolomide, cytoxan) or targeted therapies administered daily (e.g., gleevec, tarceva)
4 weeks since last cytotoxic therapy
6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., carmustine (BCNU))
Patients with life expectancy ≥ 3 months
The Karnofsky performance status (KPS) in the patient must be > 60
Eastern Cooperative Oncology Group (ECOG) Score ≤ 2
Adequate hepatic, renal, coagulation, and hematopoietic function
Hemoglobin ≥ 8 g/dL
Platelets ≥ 100,000/mm3
Neutrophils ≥ 1,500/mm3
Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
Urine protein creatinine (UPC) ratio < 1 or urine dipstick for proteinuria ≤ 2+
Alanine transaminase (ALT) < 3 ULN
Aspartate transaminase (AST) < 3 x ULN
Prothrombin time ≤ 1.2 x ULN
International Normalized Ratio (INR) < 1.5
Bilirubin < 2 x ULN
Patients with the region of interest (ROI) for FUS exposure are located close to the cortex with at least 20 mm distance beneath the skull bone and the ROI is not in the deep center brain with crucial brain functions, such as in the region of brain stem, or motor or speech regions
Patients with the potential for pregnancy and their partner must agree to use adequate contraception or be surgically sterile, or abstain from heterosexual activity starting with the first dose of treatment through at least 6 months after the last dose of BEV to avoid conception. Female patients of child-bearing potential must have a negative pregnancy test. Male patients must agree to use an adequate method of contraception starting with the first dose of treatment through 6 months after the last dose of BEV.
Able to give informed consent for the participation in the trial

Who cannot join

Patients who have had previous treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR (including bevacizumab)
New York Heart Association (NYHA) Grade II or greater congestive heart failure requiring hospitalization within 12 months prior to screening
Severe hypertension at screening (diastolic blood pressure > 100 mmHg on medication)
Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, severe cerebral or myocardial infarction, cardiac shunt, heart attack within the previous 12 months, stroke (except for transient ischemic attack; TIA) within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements
Unstable pulmonary disease or Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of screening
Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias

Show all 17Show fewer

Major surgery such as intra-thoracic, intra-abdominal or intra-pelvic (with the exception of craniotomy), open biopsy or significant traumatic injury ≤ 4 weeks prior to screening, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to screening, or who have not recovered from side effects of such procedure or injury
Known HIV positive patients, however, that HIV testing is not required for entry into this study
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of screening
Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week prior to beginning treatment
Pregnant or breast-feeding women
Known sensitivity/allergy to PET tracers, Magnetic Resonance Imaging (MRI) contrast agents, Computer Tomography (CT) contrast agents, SonoVue®, bevacizumab, or any of their components
Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
Patients who have hemorrhage or cyst within the ROI
The receipt of an investigational drug within a period of 4 weeks prior to the first FUS exposure
Use of any recreational drugs or history of drug addiction
Any other condition that, in the investigator's judgment, might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Linkou Chang Gung Memorial Hospital
Taoyuan City, 33305

Other trials in Taiwan

About this study

Official title: An Open Label, Prospective, Pilot Study to Evaluate the Efficacy and Safety of Best Physician's Choice of Standard of Care Combined With NaviFUS System in Patients With Recurrent Glioblastoma Multiforme

Read the detailed description

This trial will be divided into two stages. The study design and procedures will be as follows:

Stage 1:

Eligible patients will first be administered with BEV 10 mg/kg intravenous (IV) infusion. After 30-60 minutes, patients will receive microbubbles (MB) (SonoVue®) 0.1 mL/kg and optimal ultrasound exposure doses (based on the acoustic emission feedback FUS power control algorithm) generated from the NaviFUS System single exposure unit for up to two minutes every 2 weeks to transiently open the BBB.

After 4 weeks of treatment with BEV and single unit FUS-MB treatment, if the patient experienced BBB opening using FUS treatment and BEV IV infusion without any serious adverse effects (such as brain significant bleeding), then the patient may proceed to stage 2.

Stage 2:

Patients who complete stage 1 will enter stage 2 to receive the BEV with MB-mediated multiple units of FUS treatment for up to five minutes (but the maximum exposure time per single unit is two minutes) every 2 weeks for up to 30 weeks or until evidence of progressive disease, unacceptable toxicity, non-compliance with study follow-up, or withdrawal of consent.

After completion of study treatment, patients will be followed up for 28 days.

Conditions: Glioblastoma Multiforme, Glioblastoma, Glioma, Brain Tumor, Neoplasms, Neoplasms, Nerve Tissue
Being tested: NaviFUS System, Bevacizumab
Keywords: NaviFUS System, Blood-Brain Barrier, Focused Ultrasound, GBM, Bevacizumab
Medical subject headings: Glioblastoma, Glioma, Brain Neoplasms, Neoplasms, Neoplasms, Nerve Tissue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NaviFUS SystemDevice
Open the BBB using focused ultrasound and contrast agent SonoVue®
BevacizumabDrug
Also called Avastin
An anti-angiogenic agent to block tumor growth

Study groups in NCT04446416
Study group	Role	What they receive
Bevacizumab plus NaviFUS System	Experimental	Device: NaviFUS System BBB Disruption by FUS in recurrent GBM Microbubbles (MB) (SonoVue®) 0.1 mL/kg and optimal ultrasound exposure doses (based on the acoustic emission feedback FUS power control algorithm) generated from the NaviFUS System every 2 weeks to transiently open the BBB. Drug: Bevacizumab 10 mg/kg every 2 weeks for up to 36 weeks or until evidence of progressive disease, unacceptable toxicity, non-compliance with study follow-up, or withdrawal of consent. Receives: Device: NaviFUS System; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Event
Number and severity of adverse event
Measured: 38 weeks
Progression-free survival at 6 months (PFS-6)
Estimated rate of patients treated during 6 months without experiencing disease
Measured: 6 months

Secondary outcomes (8)

Tumor shrinkage
The tumor shrinkage rate (TSR) by measuring the longest diameter and perpendicular diameter of the main mass on MRI scans
Measured: 38 weeks
Objective response rate (ORR)
Proportion of subjects in the analysis population who have complete response (CR) or partial response (PR) using Radiologic Assessment in Neuro-Oncology criteria (RANO) criteria
Measured: 38 weeks
PET uptake
The uptake of PET (as standard uptake value - SUV and tumor-to-background ratio - TBR) in tumor and in normal contralateral gray matter before start of BEV+FUS treatment will be determined.
Measured: 38 weeks
Overall survival (OS)
OS is defined as the time in months from study treatment to death or last follow-up if alive from any cause
Measured: 38 weeks
Degree of the BBB opening
The FUS with microbubbles can temporally open the BBB. The spatial permeability of the BBB-opened region will be assessed using dynamic contrast-enhanced MRI (DCE-MRI).
Measured: 38 weeks
Corticosteroid consumption
Increase or decrease in corticosteroid use compared to baseline. The mean corticosteroid dosage prior to study treatment will be considered as the patient's baseline.
Measured: 38 weeks
Quality of life (QoL) assessment with the EORTC QLQ-C30
The validated European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30) will be used. The EORTC QLQ-C30 is a 30-item questionnaire. All of the response scale to questions are rated on a 4-point Likert scale from 1 = not at all, 2 = a little, 3 = quite a bit, to 4 = very much, and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.
Measured: 38 weeks
Quality of life (QoL) assessment with the EORTC QLQ-BN20
The EORTC QLQ-BN20 is a QoL assessment specific to brain neoplasms. The questionnaire includes 20 items. All of the response scale to questions are rated on a 4-point Likert scale from 1 = not at all, 2 = a little, 3 = quite a bit, to 4 = very much, and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.
Measured: 38 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 20204 Aug 2023

First posted24 Jun 2020
Study start21 Jul 2020
Primary completion30 Sep 2022
Study completion4 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Glioblastoma MultiformeStudies 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: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04446416
Sponsor's protocol ID: NF-2019-01
Status last verified: Apr 2026
First submitted: 16 Jun 2020
Last updated: 9 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Liu HL, Hsu PH, Lin CY, Huang CW, Chai WY, Chu PC, Huang CY, Chen PY, Yang LY, Kuo JS, Wei KC. Focused Ultrasound Enhances Central Nervous System Delivery of Bevacizumab for Malignant Glioma Treatment. Radiology. 2016 Oct;281(1):99-108. doi: 10.1148/radiol.2016152444. Epub 2016 May 18.
PubMed 27192459
Friedman HS, Prados MD, Wen PY, Mikkelsen T, Schiff D, Abrey LE, Yung WK, Paleologos N, Nicholas MK, Jensen R, Vredenburgh J, Huang J, Zheng M, Cloughesy T. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009 Oct 1;27(28):4733-40. doi: 10.1200/JCO.2008.19.8721. Epub 2009 Aug 31.
PubMed 19720927
Kreisl TN, Kim L, Moore K, Duic P, Royce C, Stroud I, Garren N, Mackey M, Butman JA, Camphausen K, Park J, Albert PS, Fine HA. Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol. 2009 Feb 10;27(5):740-5. doi: 10.1200/JCO.2008.16.3055. Epub 2008 Dec 29.
PubMed 19114704
Mainprize T, Lipsman N, Huang Y, Meng Y, Bethune A, Ironside S, Heyn C, Alkins R, Trudeau M, Sahgal A, Perry J, Hynynen K. Blood-Brain Barrier Opening in Primary Brain Tumors with Non-invasive MR-Guided Focused Ultrasound: A Clinical Safety and Feasibility Study. Sci Rep. 2019 Jan 23;9(1):321. doi: 10.1038/s41598-018-36340-0.
PubMed 30674905
Sonabend AM, Stupp R. Overcoming the Blood-Brain Barrier with an Implantable Ultrasound Device. Clin Cancer Res. 2019 Jul 1;25(13):3750-3752. doi: 10.1158/1078-0432.CCR-19-0932. Epub 2019 May 10.
PubMed 31076548
Chen KT, Tsai HC, Huang CY, Liau CT, Ho KC, Toh CH, Chuang CC, Hsu PW, Huang YC, Chang TW, Yeap MC, Chen PY, Lee CC, Lin YJ, Feng LY, Airan RD, Li G, Lim M, Liu HL, Wei KC. Combination of Neuronavigation-Guided Focused Ultrasound and Bevacizumab for Patients With Recurrent Glioblastoma: A Pilot Study. Neurosurgery. 2026 Jul 1;99(1):149-159. doi: 10.1227/neu.0000000000003851. Epub 2025 Nov 24.
PubMed 41283685

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glioblastoma Multiforme trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Prospective, Pilot Study to Evaluate the Efficacy and Safety of Best Physician's Choice of Standard of Care Combined With NaviFUS System in Patients With Recurrent Glioblastoma Multiforme
ClinicalTrials.gov ID: NCT04446416
Acronym / sponsor ID: NF-2019-01
Conditions: Glioblastoma Multiforme, Glioblastoma, Glioma, Brain Tumor, Neoplasms, Neoplasms, Nerve Tissue
Keywords: NaviFUS System, Blood-Brain Barrier, Focused Ultrasound, GBM, Bevacizumab
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: NaviFUS CorporationIndustry (pharma, biotech, devices)
Collaborators: Chang Gung Memorial Hospital
Study start: 21 Jul 2020 (actual)
Primary completion: 30 Sep 2022 (actual)
Study completion: 4 Aug 2023 (actual)
First posted: 24 Jun 2020 (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.

Detailed description

This trial will be divided into two stages. The study design and procedures will be as follows:

Stage 1:

Stage 2:

After completion of study treatment, patients will be followed up for 28 days.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Bevacizumab plus NaviFUS System	Experimental	Device: NaviFUS System, Drug: BevacizumabDevice: NaviFUS System BBB Disruption by FUS in recurrent GBM Microbubbles (MB) (SonoVue®) 0.1 mL/kg and optimal ultrasound exposure doses (based on the acoustic emission feedback FUS power control algorithm) generated from the NaviFUS System every 2 weeks to transiently open the BBB. Drug: Bevacizumab 10 mg/kg every 2 weeks for up to 36 weeks or until evidence of progressive disease, unacceptable toxicity, non-compliance with study follow-up, or withdrawal of consent.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (27 listed)

Adult male/female patients ≥ 20 years of age
Patients with histologically confirmed glioblastoma, recurrent after prior radiotherapy and temozolomide chemotherapy.
Patient may have been operated for recurrence. If operated: with measurable residual tumor
Minimum interval since completion of radiation treatment is 12 weeks
Patients if already on the steroids then should be on a stable dose of steroids for at least 7 days prior to study treatment

Key exclusion criteria (17 listed)

Patients who have had previous treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR (including bevacizumab)
New York Heart Association (NYHA) Grade II or greater congestive heart failure requiring hospitalization within 12 months prior to screening
Severe hypertension at screening (diastolic blood pressure > 100 mmHg on medication)
Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, severe cerebral or myocardial infarction, cardiac shunt, heart attack within the previous 12 months, stroke (except for transient ischemic attack; TIA) within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements
Unstable pulmonary disease or Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of screening

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
NaviFUS SystemOpen the BBB using focused ultrasound and contrast agent SonoVue®	Device	Bevacizumab plus NaviFUS System
BevacizumabAlso: AvastinAn anti-angiogenic agent to block tumor growth	Drug	Bevacizumab plus NaviFUS System

Primary outcome

Adverse Event
Time frame: 38 weeks
Number and severity of adverse event
Progression-free survival at 6 months (PFS-6)
Time frame: 6 months
Estimated rate of patients treated during 6 months without experiencing disease

8 secondary outcomes

Tumor shrinkage
Time frame: 38 weeks
Objective response rate (ORR)
Time frame: 38 weeks
PET uptake
Time frame: 38 weeks
Overall survival (OS)
Time frame: 38 weeks
Degree of the BBB opening
Time frame: 38 weeks
Corticosteroid consumption
Time frame: 38 weeks
Quality of life (QoL) assessment with the EORTC QLQ-C30
Time frame: 38 weeks
Quality of life (QoL) assessment with the EORTC QLQ-BN20
Time frame: 38 weeks

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 9 Apr 2026.
Background: PubMed 27192459Liu HL, Hsu PH, Lin CY, Huang CW, Chai WY, Chu PC, Huang CY, Chen PY, Yang LY, Kuo JS, Wei KC. Focused Ultrasound Enhances Central Nervous System Delivery of Bevacizumab for Malignant Glioma Treatment. Radiology. 2016 Oct;281(1):99-108. doi: 10.1148/radiol.2016152444. Epub 2016 May 18.
Background: PubMed 19720927Friedman HS, Prados MD, Wen PY, Mikkelsen T, Schiff D, Abrey LE, Yung WK, Paleologos N, Nicholas MK, Jensen R, Vredenburgh J, Huang J, Zheng M, Cloughesy T. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009 Oct 1;27(28):4733-40. doi: 10.1200/JCO.2008.19.8721. Epub 2009 Aug 31.
Background: PubMed 19114704Kreisl TN, Kim L, Moore K, Duic P, Royce C, Stroud I, Garren N, Mackey M, Butman JA, Camphausen K, Park J, Albert PS, Fine HA. Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol. 2009 Feb 10;27(5):740-5. doi: 10.1200/JCO.2008.16.3055. Epub 2008 Dec 29.
Background: PubMed 30674905Mainprize T, Lipsman N, Huang Y, Meng Y, Bethune A, Ironside S, Heyn C, Alkins R, Trudeau M, Sahgal A, Perry J, Hynynen K. Blood-Brain Barrier Opening in Primary Brain Tumors with Non-invasive MR-Guided Focused Ultrasound: A Clinical Safety and Feasibility Study. Sci Rep. 2019 Jan 23;9(1):321. doi: 10.1038/s41598-018-36340-0.
Background: PubMed 31076548Sonabend AM, Stupp R. Overcoming the Blood-Brain Barrier with an Implantable Ultrasound Device. Clin Cancer Res. 2019 Jul 1;25(13):3750-3752. doi: 10.1158/1078-0432.CCR-19-0932. Epub 2019 May 10.
Background: PubMed 41283685Chen KT, Tsai HC, Huang CY, Liau CT, Ho KC, Toh CH, Chuang CC, Hsu PW, Huang YC, Chang TW, Yeap MC, Chen PY, Lee CC, Lin YJ, Feng LY, Airan RD, Li G, Lim M, Liu HL, Wei KC. Combination of Neuronavigation-Guided Focused Ultrasound and Bevacizumab for Patients With Recurrent Glioblastoma: A Pilot Study. Neurosurgery. 2026 Jul 1;99(1):149-159. doi: 10.1227/neu.0000000000003851. Epub 2025 Nov 24.
Individual participant dataSharing planned: No

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Active, not recruitingPhase 3
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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.

Kuo-Chen Wei, M.D. principal investigator

Chang Gung Memorial Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NaviFUS System and Bevacizumab in people with Glioblastoma Multiforme and Glioblastoma, run by NaviFUS Corporation at 1 site in Taiwan.

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 27 inclusion and 17 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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?

Adverse Event (time frame: 38 weeks). 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?

On the ClinicalTrials.gov record for NCT04446416, which also lists 6 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 9 Apr 2026.