UrolithiasisIAUPCNLNCT07622238
IAU Percutaneous Nephrolithotripsy Study
An observational study of Urolithiasis and Kidney Calculi, run by Foundation Endourology at 2 sites in Bulgaria.
Trial summary
During the past 10-15 years, important advancements have been witnessed in percutaneous nephrolithotomy (PCNL) techniques and instrumentation. The development of miniaturized PCNL techniques and modern laser technologies has contributed to lower complication rates, alongside changes in exiting strategies and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Urolithiasis, Kidney Calculi
- What is being tested?
- Percutaneous nephrolithotomi (PCNL)
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 2 sitesBulgaria
- Study dates
- 15 Aug 2019to 15 Jun 2026
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of consecutive adult patients (18 years or older) diagnosed with renal or proximal ureteral calculi who are candidates for percutaneous stone surgery and are treated in real-world clinical practice settings. Participants are enrolled across 20 participating secondary and tertiary referral academic medical centers and hospitals globally, capturing a highly diverse and heterogeneous international population across multiple geographic regions
Who may be able to join
- Patient age 18 years or older at the time of enrollment.
- Diagnosed with single or multiple renal calculi (including complex and staghorn calculi) or proximal ureteral stones.
- Scheduled to undergo any primary or secondary percutaneous surgical stone intervention, including standard percutaneous nephrolithotomy (PCNL) or any of its miniaturized variations (Mini-PCNL, Ultra-mini PCNL, Super-mini PCNL, or Micro-PCNL).
- Voluntarily provided written informed consent for participation and data utilization.
Who cannot join
- Patient age under 18 years.
- Patients scheduled to undergo alternative primary treatment modalities for the targeted stone burden as a standalone procedure (e.g., retrograde intrarenal surgery [RIRS] or shockwave lithotripsy [SWL]).
- Presence of an active, untreated urinary tract infection (UTI) or clinical urosepsis at the time of the scheduled surgical procedure.
- Uncorrected severe coagulopathy or uncorrectable bleeding diathesis.
- Missing, incomplete, or unavailable medical charts or follow-up records rendering outcome assessment impossible.
Trial locations and contacts
2 sites in 1 country.
Bulgaria2 sites
Foundation Endourology
Sofia, Sofia-Grad, 1606
Military Medical Academy, Department of Urology and Nephrology
Sofia, Sofia-Grad, 1606
About this study
Official title: International Alliance of Urolithiasis Percutaneous Nephrolithotripsy Study
During the past 10-15 years, important advancements have been witnessed in percutaneous nephrolithotomy (PCNL) techniques and instrumentation. The development of miniaturized PCNL techniques and modern laser technologies has contributed to lower complication rates, alongside changes in exiting strategies and postoperative drainage protocols. Ultrasound is increasingly utilized to create percutaneous access, and many medical centers have transitioned to the supine position for PCNL or perform Endoscopic Combined Intrarenal Surgery (ECIRS). All these developments have helped to individualize treatment strategies and to improve clinical outcomes for patients. However, there remains an ongoing discussion regarding the optimal indications and limitations of the different miniaturized PCNL techniques compared to standard PCNL and retrograde intrarenal surgery (RIRS).
This prospective observational study is organized under the auspices of the International Alliance of Urolithiasis (IAU) and focuses on the contemporary indications, surgical techniques, instrumentation, exiting strategies, efficacy, and risk factors for intraoperative and postoperative complications of PCNL. Participating investigators will collect data on the PCNL procedures performed in their respective clinical centers prospectively for a period of 12-18 months. The study will be initiated in each clinical center following formal approval from the IAU Scientific Committee, which will also announce the conclusion of the study.
Read the detailed description
OBJECTIVES
Primary Study Objective:
To evaluate the contemporary indications, clinical efficacy, and safety profile of percutaneous nephrolithotomy (PCNL) for the treatment of renal stones.
Secondary Study Objectives:
To systematically assess intraoperative and postoperative complications of PCNL utilizing the standardized Clavien-Dindo classification system.
To identify and define specific independent risk factors contributing to intraoperative and postoperative complications following PCNL.
To execute a comparative efficacy analysis between miniaturized PCNL techniques and standard PCNL stratified by stone size and complexity.
The captured variables will undergo comprehensive statistical analysis to determine their respective effects on final procedural outcomes, stone-free rates, and perioperative complications. These parameters are categorized as follows:
Patient Preoperative Variables: Age, comorbidities, Body Mass Index (BMI), active anticoagulant/antiplatelet medications, stone configuration, presence of a solitary functioning kidney, and congenital musculoskeletal or anatomical renal abnormalities.
Preoperative Imaging and Diagnostics: Modalities utilized for surgical planning, stone density (Hounsfield units), cumulative stone size/burden, and stone number/location.
Preoperative Urinary Tract Status: Documented frequency of urinary tract infections (UTIs), identification of isolated bacterial strains, and protocols for preoperative antibiotic treatment (including specific drug types and duration).
Intraoperative Variables and Technical Access: Patient positioning (prone vs. supine variations), imaging modalities utilized for renal access puncture, definitive tract size, and the specific method of tract dilatation (balloon, metal telescopic, sequential fascial, or single-step/one-shot dilators).
Instrumentation and Efficacy Metrics: Type and size of the percutaneous access sheath, specific surgical instrumentation utilized (micro, mini, super-mini, ultra-mini, or standard PCNL), energy modalities used for lithotripsy fragmentation, and methods deployed for stone fragment extraction or evacuation.
Exiting Strategies and Postoperative Care: Choice of post-procedural drainage protocols (totally tubeless, tubeless, or standard nephrostomy tube placement, including tube type and size), time to drainage extraction, and total postoperative length of hospital stay.
Morbidity and Follow-Up: Documentation of procedural morbidity, with all adverse events classified according to the Clavien-Dindo system, alongside the subsequent management and treatment of any recorded complications.
DATA COLLECTION AND PROTOCOL MANAGEMENT Patients will be enrolled prospectively and consecutively across participating international sites, targeting a cumulative registry sample of up to 10,000 participants.
The International Alliance of Urolithiasis (IAU) Scientific Committee oversees and provides formal institutional approval for the initiation of data collection at each participating clinical center. Institutions participating in the registry must submit a formal application and cover letter to the IAU Scientific Committee.
Data collection is conducted via a secure, web-based data management system, with each approved clinical center utilizing a unique, personal username and password for system access. Every participating clinical site designates a local study coordinator responsible for ensuring accurate data entry and compliance.
To maintain data integrity, completeness, and quality control across all international centers, the IAU Scientific Committee has established a dedicated Audit Committee for continuous monitoring. Final data analysis and scientific reporting will be guided and coordinated directly by the IAU Scientific Committee.
- Conditions
- Urolithiasis, Kidney Calculi
- Being tested
- Percutaneous nephrolithotomi (PCNL)
- Keywords
- Percutaneous Nephrolithotomy, Standart PCNL, Mini-PCNL, Urolithiasis, Kidney Stones, Postoperative Complications, Efficacy
- Medical subject headings
- Urolithiasis, Kidney Calculi, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrolithotomi (PCNL)Procedure or surgery
Also called PCNL, mini PCNL
Patients included in this observational study undergo Percutaneous Nephrolithotomy (PCNL) for the treatment of renal calculi according to the established protocols of each participating center. The surgical procedure involves creating a percutaneous tract to the renal collecting system under ultrasound, fluoroscopic, or combined guidance. The study observes a wide spectrum of contemporary techniques, including standard-tract PCNL and miniaturized versions (Mini-PCNL), performed in either prone or supine positions. Specific procedural data are recorded, including the method of tract dilation (balloon, telescopic, or single-step), the type of lithotripsy energy used (laser, ultrasonic, or pneumatic), and postoperative drainage strategies (standard nephrostomy, tubeless, or stent-only). As an observational study, the choice of specific technique and equipment is determined by the treating surgeon based on clinical indications and institutional standards.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous nephrolithotripsy (PCNL) | Percutaneous nephrolithotripsy (PCNL) Receives: Procedure: Percutaneous nephrolithotomi (PCNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Stone-Free Rate (SFR)
The primary efficacy outcome defined as the percentage of patients achieving clinical success at the 1-month follow-up evaluation. Stone-free status is defined as the complete absence of residual stone fragments or the presence of clinically insignificant residual fragments (CIRF) characterized as measuring ≤ 4 mm in maximum diameter. Efficacy and fragment clearance will be verified using the participating center's standard postoperative imaging protocols, which include kidney-ureter-bladder (KUB) radiography, renal ultrasonography, or non-contrast computed tomography (NCCT) scans.
Measured: 1 month postoperatively.
Secondary outcomes (5)
Postoperative Complication Rate
The incidence and severity of postoperative adverse events and complications will be systematically recorded and graded according to the standardized Clavien-Dindo classification system. The scale ranges from Grade I (minor deviations from the normal postoperative course without need for pharmacological or surgical intervention) to Grade V (patient mortality). The final reported metrics will include the overall percentage of patients experiencing any complication (Grades I-V) and the rate of severe major complications (defined as Clavien-Dindo Grade ≥ III) within the 1-month postoperative follow-up period.
Measured: Up to 30 days postoperatively
Perioperative Hemoglobin Drop
The absolute change in serum hemoglobin levels measured in grams per deciliter (g/dL). It is calculated as the mathematical difference between the patient's baseline preoperative hemoglobin value (obtained within 48 hours prior to surgical incision) and the lowest recorded postoperative hemoglobin value obtained within the first 24 hours following the procedure. This metric serves as an objective surrogate marker for perioperative blood loss.
Measured: Within 24 hours postoperatively
Length of Hospital Stay (LOS)
The total duration of the inpatient hospital stay calculated in days. The count begins on the day of the percutaneous surgical procedure and concludes on the exact date of formal medical discharge from the urology department. A longer stay typically reflects the management of postprocedural complications or prolonged drainage requirements.
Measured: From the day of surgery/admission until formal hospital discharge, assessed up to 14 days
Total Operative Time
The cumulative duration of the surgical intervention measured continuously in minutes. The time frame is defined as the interval starting from initial patient positioning and the commencement of mandatory diagnostic cystoscopy/ureteral catheterization, up to the final secure placement of percutaneous drainage (nephrostomy tube/ureteral stent) and dressing application.
Measured: During the surgical procedure
Postoperative Change in Renal Function
The longitudinal evaluation of renal excretory capacity. This is determined by comparing preoperative baseline blood samples with follow-up laboratory values obtained at 1 month postoperatively. The primary markers analyzed will be serum creatinine levels (mg/dL or mmol/L) and the estimated Glomerular Filtration Rate (eGFR), calculated using the standardized CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation to assess any transient or permanent functional impairment.
Measured: Preoperatively up to 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start15 Aug 2019
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation Endourology
- Sponsor type
- University, hospital or other
- Collaborators
- The International Alliance of Urolithiasis
- Responsible party
- Sponsor
- Investigators
- Kemal Sarika, PhD, Study chair, Sancaktepe Training and Research Hospital, Istanbul, TurkiyeGuohua Zeng, PhD, Study chair, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, ChinaSimon Choong, PhD, Study chair, Institute of Urology, University College London Hospitals, London, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622238
- Sponsor's protocol ID
- FoundatioEndourology
- Acronym
- IAUPCNL
- Status last verified
- Oct 2026
- First submitted
- 25 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the study, including data dictionaries, will be made available to researchers whose proposed use of the data has been approved by the IAU Scientific Committee. This is intended for the purpose of further academic research and meta-analyses to improve patient care in endourology
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Alliance of Urolithiasis Percutaneous Nephrolithotripsy Study
- ClinicalTrials.gov ID
- NCT07622238
- Acronym / sponsor ID
- IAUPCNL / FoundatioEndourology
- Conditions
- Urolithiasis, Kidney Calculi
- Keywords
- Percutaneous Nephrolithotomy, Standart PCNL, Mini-PCNL, Urolithiasis, Kidney Stones, Postoperative Complications, Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Foundation EndourologyUniversity, hospital or other
- Collaborators
- The International Alliance of Urolithiasis
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 3 Jun 2026 (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.
During the past 10-15 years, important advancements have been witnessed in percutaneous nephrolithotomy (PCNL) techniques and instrumentation. The development of miniaturized PCNL techniques and modern laser technologies has contributed to lower complication rates, alongside changes in exiting strategies and postoperative drainage protocols. Ultrasound is increasingly utilized to create percutaneous access, and many medical centers have transitioned to the supine position for PCNL or perform Endoscopic Combined Intrarenal Surgery (ECIRS). All these developments have helped to individualize treatment strategies and to improve clinical outcomes for patients. However, there remains an ongoing discussion regarding the optimal indications and limitations of the different miniaturized PCNL techniques compared to standard PCNL and retrograde intrarenal surgery (RIRS).
This prospective observational study is organized under the auspices of the International Alliance of Urolithiasis (IAU) and focuses on the contemporary indications, surgical techniques, instrumentation, exiting strategies, efficacy, and risk factors for intraoperative and postoperative complications of PCNL. Participating investigators will collect data on the PCNL procedures performed in their respective clinical centers prospectively for a period of 12-18 months. The study will be initiated in each clinical center following formal approval from the IAU Scientific Committee, which will also announce the conclusion of the study.
Detailed description
OBJECTIVES
Primary Study Objective:
To evaluate the contemporary indications, clinical efficacy, and safety profile of percutaneous nephrolithotomy (PCNL) for the treatment of renal stones.
Secondary Study Objectives:
To systematically assess intraoperative and postoperative complications of PCNL utilizing the standardized Clavien-Dindo classification system.
To identify and define specific independent risk factors contributing to intraoperative and postoperative complications following PCNL.
To execute a comparative efficacy analysis between miniaturized PCNL techniques and standard PCNL stratified by stone size and complexity.
The captured variables will undergo comprehensive statistical analysis to determine their respective effects on final procedural outcomes, stone-free rates, and perioperative complications. These parameters are categorized as follows:
Patient Preoperative Variables: Age, comorbidities, Body Mass Index (BMI), active anticoagulant/antiplatelet medications, stone configuration, presence of a solitary functioning kidney, and congenital musculoskeletal or anatomical renal abnormalities.
Preoperative Imaging and Diagnostics: Modalities utilized for surgical planning, stone density (Hounsfield units), cumulative stone size/burden, and stone number/location.
Preoperative Urinary Tract Status: Documented frequency of urinary tract infections (UTIs), identification of isolated bacterial strains, and protocols for preoperative antibiotic treatment (including specific drug types and duration).
Intraoperative Variables and Technical Access: Patient positioning (prone vs. supine variations), imaging modalities utilized for renal access puncture, definitive tract size, and the specific method of tract dilatation (balloon, metal telescopic, sequential fascial, or single-step/one-shot dilators).
Instrumentation and Efficacy Metrics: Type and size of the percutaneous access sheath, specific surgical instrumentation utilized (micro, mini, super-mini, ultra-mini, or standard PCNL), energy modalities used for lithotripsy fragmentation, and methods deployed for stone fragment extraction or evacuation.
Exiting Strategies and Postoperative Care: Choice of post-procedural drainage protocols (totally tubeless, tubeless, or standard nephrostomy tube placement, including tube type and size), time to drainage extraction, and total postoperative length of hospital stay.
Morbidity and Follow-Up: Documentation of procedural morbidity, with all adverse events classified according to the Clavien-Dindo system, alongside the subsequent management and treatment of any recorded complications.
DATA COLLECTION AND PROTOCOL MANAGEMENT Patients will be enrolled prospectively and consecutively across participating international sites, targeting a cumulative registry sample of up to 10,000 participants.
The International Alliance of Urolithiasis (IAU) Scientific Committee oversees and provides formal institutional approval for the initiation of data collection at each participating clinical center. Institutions participating in the registry must submit a formal application and cover letter to the IAU Scientific Committee.
Data collection is conducted via a secure, web-based data management system, with each approved clinical center utilizing a unique, personal username and password for system access. Every participating clinical site designates a local study coordinator responsible for ensuring accurate data entry and compliance.
To maintain data integrity, completeness, and quality control across all international centers, the IAU Scientific Committee has established a dedicated Audit Committee for continuous monitoring. Final data analysis and scientific reporting will be guided and coordinated directly by the IAU Scientific Committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous nephrolithotripsy (PCNL) | – | Procedure: Percutaneous nephrolithotomi (PCNL)Percutaneous nephrolithotripsy (PCNL) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of consecutive adult patients (18 years or older) diagnosed with renal or proximal ureteral calculi who are candidates for percutaneous stone surgery and are treated in real-world clinical practice settings. Participants are enrolled across 20 participating secondary and tertiary referral academic medical centers and hospitals globally, capturing a highly diverse and heterogeneous international population across multiple geographic regions
Key inclusion criteria (4 listed)
- Patient age 18 years or older at the time of enrollment.
- Diagnosed with single or multiple renal calculi (including complex and staghorn calculi) or proximal ureteral stones.
- Scheduled to undergo any primary or secondary percutaneous surgical stone intervention, including standard percutaneous nephrolithotomy (PCNL) or any of its miniaturized variations (Mini-PCNL, Ultra-mini PCNL, Super-mini PCNL, or Micro-PCNL).
- Voluntarily provided written informed consent for participation and data utilization.
Key exclusion criteria (5 listed)
- Patient age under 18 years.
- Patients scheduled to undergo alternative primary treatment modalities for the targeted stone burden as a standalone procedure (e.g., retrograde intrarenal surgery [RIRS] or shockwave lithotripsy [SWL]).
- Presence of an active, untreated urinary tract infection (UTI) or clinical urosepsis at the time of the scheduled surgical procedure.
- Uncorrected severe coagulopathy or uncorrectable bleeding diathesis.
- Missing, incomplete, or unavailable medical charts or follow-up records rendering outcome assessment impossible.
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 nephrolithotomi (PCNL)Also: PCNL, mini PCNLPatients included in this observational study undergo Percutaneous Nephrolithotomy (PCNL) for the treatment of renal calculi according to the established protocols of each participating center. The surgical procedure involves creating a percutaneous tract to the renal collecting system under ultrasound, fluoroscopic, or combined guidance. The study observes a wide spectrum of contemporary techniques, including standard-tract PCNL and miniaturized versions (Mini-PCNL), performed in either prone or supine positions. Specific procedural data are recorded, including the method of tract dilation (balloon, telescopic, or single-step), the type of lithotripsy energy used (laser, ultrasonic, or pneumatic), and postoperative drainage strategies (standard nephrostomy, tubeless, or stent-only). As an observational study, the choice of specific technique and equipment is determined by the treating surgeon based on clinical indications and institutional standards. | Procedure or surgery | Percutaneous nephrolithotripsy (PCNL) |
Primary outcome
Primary Stone-Free Rate (SFR)
Time frame: 1 month postoperatively.
The primary efficacy outcome defined as the percentage of patients achieving clinical success at the 1-month follow-up evaluation. Stone-free status is defined as the complete absence of residual stone fragments or the presence of clinically insignificant residual fragments (CIRF) characterized as measuring ≤ 4 mm in maximum diameter. Efficacy and fragment clearance will be verified using the participating center's standard postoperative imaging protocols, which include kidney-ureter-bladder (KUB) radiography, renal ultrasonography, or non-contrast computed tomography (NCCT) scans.
5 secondary outcomes
Postoperative Complication Rate
Time frame: Up to 30 days postoperatively
Perioperative Hemoglobin Drop
Time frame: Within 24 hours postoperatively
Length of Hospital Stay (LOS)
Time frame: From the day of surgery/admission until formal hospital discharge, assessed up to 14 days
Total Operative Time
Time frame: During the surgical procedure
Postoperative Change in Renal Function
Time frame: Preoperatively up to 1 month postoperatively
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 15 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the study, including data dictionaries, will be made available to researchers whose proposed use of the data has been approved by the IAU Scientific Committee. This is intended for the purpose of further academic research and meta-analyses to improve patient care in endourology
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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.
Kemal Sarika, PhD study chair
Sancaktepe Training and Research Hospital, Istanbul, Turkiye
Guohua Zeng, PhD study chair
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
Simon Choong, PhD study chair
Institute of Urology, University College London Hospitals, London, United Kingdom
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis and Kidney Calculi, run by Foundation Endourology at 2 sites in Bulgaria.
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 4 inclusion and 5 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria. 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?
Primary Stone-Free Rate (SFR) (time frame: 1 month postoperatively.). 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 15 Oct 2026.