Radiation CystitisHEMOCCNCT04701749
Study of the Effects of Anticoagulant Interruption Covered by Percutaneous Left Atrial Occlusion in Patients With Chronic Atrial Fibrillation and Radiation Cystitis at Risk of Bleeding
An observational study of Radiation Cystitis and Non-valvular Atrial Fibrillation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The etiology of the radiation cystitis is a pelvic irradiation generally performed as part of the treatment of prostate cancer. The incidence is 50,000 new cases per year. Approximately 35% of prostate cancer treatment is radiotherapy. The prevalence of haematuric radiation cystitis is 4-5% (about 800 patients). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Cystitis, Non-valvular Atrial Fibrillation
- What is being tested?
- Percutaneous left atrial closure and No Percutaneous left atrial closure
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2021to Sep 2030
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: patients with at least one hematuria while on anticoagulant therapy for non-valvular atrial fibrillation
Who may be able to join
- Patient over 18 years old benefiting a social security sheme.
- Patient with hematuric radiation bladder associated with a non valvular anticoagulated atrial fibrillation.
Who cannot join
- All the other hematuria's reasons
- Other reason of anti platelet agent using than atrial fibrillation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Clermont Ferrand
Clermont-Ferrand, 63003
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Laurent GUY
About this study
The etiology of the radiation cystitis is a pelvic irradiation generally performed as part of the treatment of prostate cancer. The incidence is 50,000 new cases per year. Approximately 35% of prostate cancer treatment is radiotherapy. The prevalence of haematuric radiation cystitis is 4-5% (about 800 patients).
One of the complications of radiation cystitis is persistent hematuria. There is currently no curative treatment for this hematuria. There are few treatment options with a random probability of improvement of this symptomatology. These haematurias are rarely resolved spontaneously and most of the time involve emergency room management with +/- invasive procedures, sometimes by hospitalisation, always with a significant psychological impact on the patient.
Read more
Furthermore, lifetime anticoagulant treatment considerably increases the likelihood of bladder bleeding. This is the case of patients being followed for Atrial Fibrillation Cardiac Arrhythmia (AFCA), which by definition carries a major cardioembolic risk, and who will be of particular interest in this study.
In recent years, cardiologists have developed an alternative to anticoagulants: left atrial appendage closure or left atrial occlusion (LAO) . This procedure consists of inserting a nitinol prosthesis in the left atrium, the site of more than 90% of thrombi formation in non-valvular atrial fibrillation. This minimally invasive procedure lasts about 15 minutes and is performed during a 48-hour hospitalization. Anticoagulants are stopped the day after the setting up procedure. Several studies have shown non-inferiority of atrial closure and anticoagulants to thromboembolic events in non-valvular atrial fibrillation. In addition, LAO allows the permanent discontinuation of anticoagulants, associated with the cessation of anticoagulant bleeding adverse events.
While studies have been conducted on the impact of this technique on patients monitored in cardiology, no studies evaluate the value of LAO in anticoagulated patients with a hematuric radiation cystitis. This tprocedure is already used in routine care for patients followed in urology, and has shown encouraging results, since 8 out of 10 patients saw a significant reduction in the number of haematurias, but it has never yet been scientifically proven to be effective, hence the aim of this study.
The interest of this study will therefore be :
- To evaluate the potential benefit of left atrial appendage closure on the number of episodes of hematuria.
- To evaluate the economic benefit in reducing the number of hospitalizations, surgeries and complications for hematuria as well as the discontinuation of anticoagulants.
As the patient's data must be retrieved regardless of the patient's subsequent management (with or without a cardiac procedure) within the framework of the HEMOCC protocol, it will be proposed to the patient as soon as he or she is consulting for haematuria on radiation cystitis. The patient will be followed for 3 years.
The mainly descriptive analyses will be collected in the form of a register and carried out by a biostatistician from Clermont-Ferrand University Hospital.
Read the detailed description
Prospective single-centre observational study involving the creation of a data registry of patients with anticoagulation-treated non-valvular atrial fibrillation with hematuria on radiation cystitis.
Patients who present a hematuria on radial bladder associated with anticoagulated atrial fibrillation will be recruited into the protocol by an urologist from Gabriel MONTPIED UHC once they have presented at least one episode of hematuria on radial bladder under anticoagulant treatment in the context of a non-valvular ACFA, and once they have given their agreement to participate in the HEMOCC research protocol.
A research associate will meet the patient to finalize the administrative and practical aspects of inclusion and the collection of retrospective data. Regardless of whether or not left atrial occlusion is performed, the patient's data included in the protocol will be collected.
The urologist will then refer the patient to Pr ESCHALIER's cardiology department for cardiological advice regarding an indication of percutaneous occlusion of the left atrium (running walk).
If LAO is indicated and the patient agrees to the procedure, then the procedure will be scheduled.
- Being tested
- Percutaneous left atrial closure, No Percutaneous left atrial closure
- Keywords
- radiation cystitis, Hematuria, Left atrial appendage closure or left atrial occlusion (LAO)
- Medical subject headings
- Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous left atrial closureDevice
Percutaneous left atrial closure was performed under general anesthesia with angiographic control and transesophageal echocardiography. The procedure takes between 15 and 20 minutes. This begins with a right femoral venipuncture, progression of the guide in the right atrium allowing atrial trans-septal puncture to catheterize the left atrium. A nitinol prosthesis is implanted (Boston Watchman) at the ostium of the left auricle between the left superior pulmonary vein and the circumflex artery. After a tensile test verifying the stability of the prosthesis, the absence of peri-prosthetic leakage is verified by ETO and angiographic control. The patient is monitored 48 hours before discharge to eliminate the appearance of pericardial effusion and prosthetic embolization. Aspirin 75 mg monotherapy is started the same day with stopping anticoagulation.
No Percutaneous left atrial closureOther
No Percutaneous left atrial closure
| Study group | Role | What they receive |
|---|---|---|
| with atrial closure | Not described Receives: Device: Percutaneous left atrial closure | |
| without atrial occlusion | Not described Receives: Other: No Percutaneous left atrial closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
Measured: Baseline (Month 0)
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
Measured: Month 3
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
Measured: Month 6
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
Measured: Month 9
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
Measured: Month 12
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
Measured: Month 18
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
Measured: Month 24
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
Measured: Month 30
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
Measured: Month 36
Secondary outcomes (27)
Number of days hospitalizations for hematuria
assessed by phone contact
Measured: Baseline (Month 0)
Number of days hospitalizations for hematuria
assessed by phone contact
Measured: Month 3
Number of days hospitalizations for hematuria
assessed by phone contact
Measured: Month 6
Number of days hospitalizations for hematuria
assessed by phone contact
Measured: Month 9
Number of days hospitalizations for hematuria
assessed by phone contact
Measured: Month 12
Number of days hospitalizations for hematuria
assessed by phone contact
Measured: Month 18
Number of days hospitalizations for hematuria
assessed by phone contact
Measured: Month 24
Number of days hospitalizations for hematuria
assessed by phone contact
Measured: Month 30
Number of days hospitalizations for hematuria
assessed by phone contact
Measured: Month 36
duration of hematuria episodes
assessed by phone contact
Measured: Baseline (Month 0)
duration of hematuria episodes
assessed by phone contact
Measured: Month 3
duration of hematuria episodes
assessed by phone contact
Measured: Month 6
duration of hematuria episodes
assessed by phone contact
Measured: Month 9
duration of hematuria episodes
assessed by phone contact
Measured: Month 12
duration of hematuria episodes
assessed by phone contact
Measured: Month 18
duration of hematuria episodes
assessed by phone contact
Measured: Month 24
duration of hematuria episodes
assessed by phone contact
Measured: Month 30
duration of hematuria episodes
assessed by phone contact
Measured: Month 36
number of hematuria surveys
assessed by phone contact
Measured: Baseline (Month 0)
number of hematuria surveys
assessed by phone contact
Measured: Month 3
number of hematuria surveys
assessed by phone contact
Measured: Month 6
number of hematuria surveys
assessed by phone contact
Measured: Month 9
number of hematuria surveys
assessed by phone contact
Measured: Month 12
number of hematuria surveys
assessed by phone contact
Measured: Month 18
number of hematuria surveys
assessed by phone contact
Measured: Month 24
number of hematuria surveys
assessed by phone contact
Measured: Month 30
number of hematuria surveys
assessed by phone contact
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start24 Feb 2021
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation CystitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent GUY, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701749
- Sponsor's protocol ID
- RNI 2020 GUY
- Other IDs
- 2020-A02246-33
- Acronym
- HEMOCC
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Anticoagulant Interruption Covered by Percutaneous Left Atrial Occlusion in Patients With Chronic Atrial Fibrillation and Radiation Cystitis at Risk of Bleeding
- ClinicalTrials.gov ID
- NCT04701749
- Acronym / sponsor ID
- HEMOCC / RNI 2020 GUY
- Keywords
- radiation cystitis, Hematuria, Left atrial appendage closure or left atrial occlusion (LAO)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 8 Jan 2021 (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 etiology of the radiation cystitis is a pelvic irradiation generally performed as part of the treatment of prostate cancer. The incidence is 50,000 new cases per year. Approximately 35% of prostate cancer treatment is radiotherapy. The prevalence of haematuric radiation cystitis is 4-5% (about 800 patients).
One of the complications of radiation cystitis is persistent hematuria. There is currently no curative treatment for this hematuria. There are few treatment options with a random probability of improvement of this symptomatology. These haematurias are rarely resolved spontaneously and most of the time involve emergency room management with +/- invasive procedures, sometimes by hospitalisation, always with a significant psychological impact on the patient.
Furthermore, lifetime anticoagulant treatment considerably increases the likelihood of bladder bleeding. This is the case of patients being followed for Atrial Fibrillation Cardiac Arrhythmia (AFCA), which by definition carries a major cardioembolic risk, and who will be of particular interest in this study.
In recent years, cardiologists have developed an alternative to anticoagulants: left atrial appendage closure or left atrial occlusion (LAO) . This procedure consists of inserting a nitinol prosthesis in the left atrium, the site of more than 90% of thrombi formation in non-valvular atrial fibrillation. This minimally invasive procedure lasts about 15 minutes and is performed during a 48-hour hospitalization. Anticoagulants are stopped the day after the setting up procedure. Several studies have shown non-inferiority of atrial closure and anticoagulants to thromboembolic events in non-valvular atrial fibrillation. In addition, LAO allows the permanent discontinuation of anticoagulants, associated with the cessation of anticoagulant bleeding adverse events.
While studies have been conducted on the impact of this technique on patients monitored in cardiology, no studies evaluate the value of LAO in anticoagulated patients with a hematuric radiation cystitis. This tprocedure is already used in routine care for patients followed in urology, and has shown encouraging results, since 8 out of 10 patients saw a significant reduction in the number of haematurias, but it has never yet been scientifically proven to be effective, hence the aim of this study.
The interest of this study will therefore be :
- To evaluate the potential benefit of left atrial appendage closure on the number of episodes of hematuria.
- To evaluate the economic benefit in reducing the number of hospitalizations, surgeries and complications for hematuria as well as the discontinuation of anticoagulants.
As the patient's data must be retrieved regardless of the patient's subsequent management (with or without a cardiac procedure) within the framework of the HEMOCC protocol, it will be proposed to the patient as soon as he or she is consulting for haematuria on radiation cystitis. The patient will be followed for 3 years.
The mainly descriptive analyses will be collected in the form of a register and carried out by a biostatistician from Clermont-Ferrand University Hospital.
Detailed description
Prospective single-centre observational study involving the creation of a data registry of patients with anticoagulation-treated non-valvular atrial fibrillation with hematuria on radiation cystitis.
Patients who present a hematuria on radial bladder associated with anticoagulated atrial fibrillation will be recruited into the protocol by an urologist from Gabriel MONTPIED UHC once they have presented at least one episode of hematuria on radial bladder under anticoagulant treatment in the context of a non-valvular ACFA, and once they have given their agreement to participate in the HEMOCC research protocol.
A research associate will meet the patient to finalize the administrative and practical aspects of inclusion and the collection of retrospective data. Regardless of whether or not left atrial occlusion is performed, the patient's data included in the protocol will be collected.
The urologist will then refer the patient to Pr ESCHALIER's cardiology department for cardiological advice regarding an indication of percutaneous occlusion of the left atrium (running walk).
If LAO is indicated and the patient agrees to the procedure, then the procedure will be scheduled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with atrial closure | – | Device: Percutaneous left atrial closure |
| without atrial occlusion | – | Other: No Percutaneous left atrial closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with at least one hematuria while on anticoagulant therapy for non-valvular atrial fibrillation
Key inclusion criteria (2 listed)
- Patient over 18 years old benefiting a social security sheme.
- Patient with hematuric radiation bladder associated with a non valvular anticoagulated atrial fibrillation.
Key exclusion criteria (2 listed)
- All the other hematuria's reasons
- Other reason of anti platelet agent using than atrial fibrillation
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 |
|---|---|---|
| Percutaneous left atrial closurePercutaneous left atrial closure was performed under general anesthesia with angiographic control and transesophageal echocardiography. The procedure takes between 15 and 20 minutes. This begins with a right femoral venipuncture, progression of the guide in the right atrium allowing atrial trans-septal puncture to catheterize the left atrium. A nitinol prosthesis is implanted (Boston Watchman) at the ostium of the left auricle between the left superior pulmonary vein and the circumflex artery. After a tensile test verifying the stability of the prosthesis, the absence of peri-prosthetic leakage is verified by ETO and angiographic control. The patient is monitored 48 hours before discharge to eliminate the appearance of pericardial effusion and prosthetic embolization. Aspirin 75 mg monotherapy is started the same day with stopping anticoagulation. | Device | with atrial closure |
| No Percutaneous left atrial closureNo Percutaneous left atrial closure | Other | without atrial occlusion |
Primary outcome
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
Time frame: Baseline (Month 0)
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
Time frame: Month 3
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
Time frame: Month 6
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
Time frame: Month 9
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
Time frame: Month 12
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
Time frame: Month 18
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
Time frame: Month 24
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
Time frame: Month 30
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
Time frame: Month 36
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
27 secondary outcomes
Number of days hospitalizations for hematuria
Time frame: Baseline (Month 0)
Number of days hospitalizations for hematuria
Time frame: Month 3
Number of days hospitalizations for hematuria
Time frame: Month 6
Number of days hospitalizations for hematuria
Time frame: Month 9
Number of days hospitalizations for hematuria
Time frame: Month 12
Number of days hospitalizations for hematuria
Time frame: Month 18
Number of days hospitalizations for hematuria
Time frame: Month 24
Number of days hospitalizations for hematuria
Time frame: Month 30
Number of days hospitalizations for hematuria
Time frame: Month 36
duration of hematuria episodes
Time frame: Baseline (Month 0)
duration of hematuria episodes
Time frame: Month 3
duration of hematuria episodes
Time frame: Month 6
duration of hematuria episodes
Time frame: Month 9
duration of hematuria episodes
Time frame: Month 12
duration of hematuria episodes
Time frame: Month 18
duration of hematuria episodes
Time frame: Month 24
duration of hematuria episodes
Time frame: Month 30
duration of hematuria episodes
Time frame: Month 36
number of hematuria surveys
Time frame: Baseline (Month 0)
number of hematuria surveys
Time frame: Month 3
number of hematuria surveys
Time frame: Month 6
number of hematuria surveys
Time frame: Month 9
number of hematuria surveys
Time frame: Month 12
number of hematuria surveys
Time frame: Month 18
number of hematuria surveys
Time frame: Month 24
number of hematuria surveys
Time frame: Month 30
number of hematuria surveys
Time frame: Month 36
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 19 Mar 2026.
Related trials for Radiation Cystitis
RecruitingObservational study
Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)
Pelvic Toxicity, Radiation Toxicity
RecruitingObservational study
Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
Radiation Cystitis, Urinary Tract Infection (Diagnosis)
Not yet recruitingEarly Phase 1
Clinical Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Combined With Sodium Hyaluronate Intravesical Instillation in the Treatment of Radiation Cystitis
Radiation Cystitis
RecruitingObservational study
Soft Tissue Radiation Injury; Patient Reported Evaluation in a Single Centre Cohort Study (STRIPE)
Cystitis, Radio Induced, Soft Tissue Radionecrosis (STRN)
Not yet recruiting
Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer
Bladder Cancer, Radiation Cystitis
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.
Laurent GUY principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Cystitis and Non-valvular Atrial Fibrillation, run by University Hospital, Clermont-Ferrand 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 2 inclusion and 2 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 19 Mar 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 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?
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 Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants (time frame: Baseline (Month 0)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.