NephrolithiasisNCT04389853
Mini-PNCL vs fURS in Management of Nephrolithiasis
A study testing Flexible ureteroscopy and Mini-percutaneous nephrolithotomy in people with Nephrolithiasis and Kidney Stone, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.
Trial summary
The prevalence of nephrolithiasis is increasing over the last two decades, and kidney stones is a recurrent disorder, with lifetime recurrence risks reported to be as high as 50%. One of the most challenging stones is the lower pole (LP) nephrolithiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis, Kidney Stone
- What is being tested?
- Flexible ureteroscopy and Mini-percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2020to 24 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects over 18 years of age at the time of enrollment.
- Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx.
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Who cannot join
- Congenital anatomic anomalies of the kidney, ureters or bladder.
- Previous ipsilateral renal surgery within past five years.
- Patients with ipsilateral distal ureteral stones or stricture.
- Stone size > 20 mL or multiple kidney stones in different calyces.
- Previous SWL treatment for the same stone.
- Patients presented with a previously inserted ipsilateral ureteral stent.
Show all 13Show fewer
- Participants with active urinary tract infection until appropriately treated
- Uncorrected coagulopathy (anticoagulants or blood thinners which cannot be withheld before surgery).
- Pregnancy or morbid obesity
- Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
- Participants who are uncooperative or cannot follow instructions.
- Participants who lack the capacity to provide free and informed written consent.
- Patients with solitary kidney.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Thunder Bay Regional Health Sciences Centre/Thunder Bay Regional Health Research Institute
Thunder Bay, Ontario, P7B6V4
About this study
Official title: Ambulatory Tubeless Mini Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery in the Management of Nephrolithiasis: A Randomized Controlled Clinical Study
The prevalence of nephrolithiasis is increasing over the last two decades, and kidney stones is a recurrent disorder, with lifetime recurrence risks reported to be as high as 50%. One of the most challenging stones is the lower pole (LP) nephrolithiasis.
The standard management of lower pole stones (LPS), is still controversial especially for stones smaller than 20 mm, with retrograde intrarenal surgery (RIRS) and mini-PCNL (miniperc) both demonstrated to be safe and effective methods for treating LPS with a diameter of 1-2 cm.
Read more
Selecting the optimal modality for treating renal calculi is challenging, as both techniques may be associated with different patient benefits and risk profiles. Despite the evolution of mini-PCNL and fURS techniques into clinical practice, there is a lack of comparative clinical data assessing SFRs and complication rates.
To the investigators' knowledge, no previous studies have addressed the outcome of ambulatory tubeless miniperc as a same day procedure, which this study will look to assess. The investigators are planning to discharge all participants home the night of surgery, without admission or insertion of nephrostomy tube. This will decrease the morbidity of miniperc and encourage head-to-head comparison with fURS in a prospective randomized protocol.
Read the detailed description
The prevalence of nephrolithiasis is increasing over the last two decades, and kidney stones is a recurrent disorder, with lifetime recurrence risks reported to be as high as 50%. One of the most challenging stones is the lower pole (LP) nephrolithiasis. This could be explained by its antigravity location, acute angle with the renal pelvis and the narrow angle of the infundibulum. Therefore, the optimal management of LP calculi continues to be a dilemma. The standard management of lower pole stones (LPS), is still controversial especially for stones smaller than 20 mm, with competing interventions possessing advantages and disadvantages. Treatment options include percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), or shockwave lithotripsy (SWL).
PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, surgeons have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs).
Another alternative option is RIRS. RIRS has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding.
RIRS and miniperc are both safe and effective methods for treating LPS with a diameter of 1-2 cm. The SFRs were comparable at the first postoperative day (90.2% vs. 93.2%) and the second month postoperatively (93.8% vs. 95.1%), for RIRS and miniperc, respectively. However, miniperc was associated with significant longer hospital stay and higher hospitalization costs.
Therefore, selecting the optimal modality for treating renal calculi is challenging, as both techniques may be associated with different patient benefits and risk profiles. Despite the evolution of mini-PCNL and fURS techniques into clinical practice, there is a lack of comparative clinical data assessing SFRs and complication rates.
To the investigators' knowledge, no previous studies have addressed the outcome of ambulatory tubeless miniperc as a same day procedure, which this study will look to assess. The investigators are planning to discharge all participants home the night of surgery, without admission or insertion of nephrostomy tube. This should decrease the morbidity of miniperc and encourage head-to-head comparison with fURS in a prospective randomized protocol.
The investigators will attempt to address whether there is a difference in clinical outcome between ambulatory mini percutaneous nephrolithotomy and flexible ureteroscopy in the management of lower pole kidney stones?
- Conditions
- Nephrolithiasis, Kidney Stone
- Being tested
- Flexible ureteroscopy, Mini-percutaneous nephrolithotomy
- Medical subject headings
- Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible ureteroscopyProcedure or surgery
Retograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding.
Mini-percutaneous nephrolithotomyProcedure or surgery
PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs).
| Study group | Role | What they receive |
|---|---|---|
| Flexible ureteroscopy (fURS) | Active comparator | Retrograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding. Receives: Procedure: Flexible ureteroscopy |
| Mini-percutaneous nephrolithotomy (mini-PCNL) | Active comparator | PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs)4 Receives: Procedure: Mini-percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free status
Operation success will be evaluated with a non-contrast computed tomography (CT) scan on the first post-operative day, as per standard of care. Presence or absence of kidney stones will be confirmed via CT scan
Measured: 1-day
Stone-free status
Operation success will be re-evaluated with a non-contrast computed tomography (CT) scan at 4-weeks post-operation, as per standard of care. Presence or absence of kidney stones will be confirmed via CT scan
Measured: 4-weeks post-op
Secondary outcomes (5)
To compare safety measures
Adverse events including perioperative bleeding, operative time, fluoroscopy time, need for blood transfusion, stone composition, fragmentation type, ureteral stenting, and urinary tract infection will be recorded intra and post-op
Measured: 4 weeks
To compare stone free status of single use vs reusable fURS
Subgroup analysis comparing two types of fURS treatments. In this study, participants randomized to the fURS cohort may receive either single use or reusable fURS are their standard of care treatment. The investigators plan to conduct a subgroup analysis comparing stone-free status 1-day post-op using a standard of care non-contrast CT scan.
Measured: 1-day post-op
To compare stone free status of single use vs reusable fURS
Subgroup analysis comparing two types of fURS treatments. In this study, participants randomized to the fURS cohort may receive either single use or reusable fURS are their standard of care treatment. The investigators plan to conduct a subgroup analysis comparing stone-free status 4-weeks post-op using a standard of care non-contrast CT scan.
Measured: 4-weeks post-op
Assess the postoperative pain between both techniques
Post-surgical pain will be assessed using a Visual Analog Scale (VAS) questionnaire. This questionnaire consists of 1 question asking participants to choose a number from 0-10 describing their pain at the current moment. A lower score indicates less pain, while a higher score indicates a higher degree of pain. For example a score of 0 indicates "No Pain", while a score of 10 indicates "Unbearable Pain".
Measured: 1-day post-op
Assess the postoperative pain between both techniques
Post-surgical pain will be assessed using a Visual Analog Scale (VAS) questionnaire. This questionnaire consists of 1 question asking participants to choose a number from 0-10 describing their pain at the current moment. A lower score indicates less pain, while a higher score indicates a higher degree of pain. For example a score of 0 indicates "No Pain", while a score of 10 indicates "Unbearable Pain".
Measured: 4-weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start5 Oct 2020
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Study comparing two standard of care treatments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thunder Bay Regional Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Elmansy, Thunder Bay Regional Health Research Institute
- Investigators
- Hazem Elmansy, MD, Principal investigator, Thunder Bay Regional Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389853
- Sponsor's protocol ID
- RP-645
- Status last verified
- Aug 2024
- First submitted
- 5 May 2020
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share participant data with other researchers. Findings may be presented locally, nationally, and internationally at conferences. Any data presented will be de-identified and grouped prior to use, as to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Tubeless Mini Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery in the Management of Nephrolithiasis: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04389853
- Acronym / sponsor ID
- RP-645
- Conditions
- Nephrolithiasis, Kidney Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Thunder Bay Regional Health Research InstituteUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 15 May 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.
The prevalence of nephrolithiasis is increasing over the last two decades, and kidney stones is a recurrent disorder, with lifetime recurrence risks reported to be as high as 50%. One of the most challenging stones is the lower pole (LP) nephrolithiasis.
The standard management of lower pole stones (LPS), is still controversial especially for stones smaller than 20 mm, with retrograde intrarenal surgery (RIRS) and mini-PCNL (miniperc) both demonstrated to be safe and effective methods for treating LPS with a diameter of 1-2 cm.
Selecting the optimal modality for treating renal calculi is challenging, as both techniques may be associated with different patient benefits and risk profiles. Despite the evolution of mini-PCNL and fURS techniques into clinical practice, there is a lack of comparative clinical data assessing SFRs and complication rates.
To the investigators' knowledge, no previous studies have addressed the outcome of ambulatory tubeless miniperc as a same day procedure, which this study will look to assess. The investigators are planning to discharge all participants home the night of surgery, without admission or insertion of nephrostomy tube. This will decrease the morbidity of miniperc and encourage head-to-head comparison with fURS in a prospective randomized protocol.
Detailed description
The prevalence of nephrolithiasis is increasing over the last two decades, and kidney stones is a recurrent disorder, with lifetime recurrence risks reported to be as high as 50%. One of the most challenging stones is the lower pole (LP) nephrolithiasis. This could be explained by its antigravity location, acute angle with the renal pelvis and the narrow angle of the infundibulum. Therefore, the optimal management of LP calculi continues to be a dilemma. The standard management of lower pole stones (LPS), is still controversial especially for stones smaller than 20 mm, with competing interventions possessing advantages and disadvantages. Treatment options include percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), or shockwave lithotripsy (SWL).
PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, surgeons have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs).
Another alternative option is RIRS. RIRS has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding.
RIRS and miniperc are both safe and effective methods for treating LPS with a diameter of 1-2 cm. The SFRs were comparable at the first postoperative day (90.2% vs. 93.2%) and the second month postoperatively (93.8% vs. 95.1%), for RIRS and miniperc, respectively. However, miniperc was associated with significant longer hospital stay and higher hospitalization costs.
Therefore, selecting the optimal modality for treating renal calculi is challenging, as both techniques may be associated with different patient benefits and risk profiles. Despite the evolution of mini-PCNL and fURS techniques into clinical practice, there is a lack of comparative clinical data assessing SFRs and complication rates.
To the investigators' knowledge, no previous studies have addressed the outcome of ambulatory tubeless miniperc as a same day procedure, which this study will look to assess. The investigators are planning to discharge all participants home the night of surgery, without admission or insertion of nephrostomy tube. This should decrease the morbidity of miniperc and encourage head-to-head comparison with fURS in a prospective randomized protocol.
The investigators will attempt to address whether there is a difference in clinical outcome between ambulatory mini percutaneous nephrolithotomy and flexible ureteroscopy in the management of lower pole kidney stones?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Study comparing two standard of care treatments.
| Arm | Type | Receives |
|---|---|---|
| Flexible ureteroscopy (fURS) | Active comparator | Procedure: Flexible ureteroscopyRetrograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding. |
| Mini-percutaneous nephrolithotomy (mini-PCNL) | Active comparator | Procedure: Mini-percutaneous nephrolithotomyPCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs)4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects over 18 years of age at the time of enrollment.
- Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx.
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Key exclusion criteria (13 listed)
- Congenital anatomic anomalies of the kidney, ureters or bladder.
- Previous ipsilateral renal surgery within past five years.
- Patients with ipsilateral distal ureteral stones or stricture.
- Stone size > 20 mL or multiple kidney stones in different calyces.
- Previous SWL treatment for the same stone.
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 |
|---|---|---|
| Flexible ureteroscopyRetograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding. | Procedure or surgery | Flexible ureteroscopy (fURS) |
| Mini-percutaneous nephrolithotomyPCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs). | Procedure or surgery | Mini-percutaneous nephrolithotomy (mini-PCNL) |
Primary outcome
Stone-free status
Time frame: 1-day
Operation success will be evaluated with a non-contrast computed tomography (CT) scan on the first post-operative day, as per standard of care. Presence or absence of kidney stones will be confirmed via CT scan
Stone-free status
Time frame: 4-weeks post-op
Operation success will be re-evaluated with a non-contrast computed tomography (CT) scan at 4-weeks post-operation, as per standard of care. Presence or absence of kidney stones will be confirmed via CT scan
5 secondary outcomes
To compare safety measures
Time frame: 4 weeks
To compare stone free status of single use vs reusable fURS
Time frame: 1-day post-op
To compare stone free status of single use vs reusable fURS
Time frame: 4-weeks post-op
Assess the postoperative pain between both techniques
Time frame: 1-day post-op
Assess the postoperative pain between both techniques
Time frame: 4-weeks post-op
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 16 Aug 2024.
- Individual participant dataSharing planned: No. There are no plans to share participant data with other researchers. Findings may be presented locally, nationally, and internationally at conferences. Any data presented will be de-identified and grouped prior to use, as to protect participant confidentiality.
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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.
Hazem Elmansy, MD principal investigator
Thunder Bay Regional Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible ureteroscopy and Mini-percutaneous nephrolithotomy in people with Nephrolithiasis and Kidney Stone, run by Thunder Bay Regional Health Research Institute 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 4 inclusion and 13 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 16 Aug 2024. 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.
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?
Stone-free status (time frame: 1-day). 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?
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 16 Aug 2024.