NephrolithiasisNCT06469736
Comparison Between Ureterorenoscopy With Lithotripsy Alone Versus Combination With Hydrogel for Kidney Stone Removal
A study of Nephrolithiasis and Lithotripsy, Laser, run by Technical University of Munich at 1 site in Germany.
Trial summary
The incidence of kidney stones (urolithiasis) has surged in both developing and developed countries, affecting approximately 15% of the global population. From 2010 to 2019, diagnoses of kidney and ureteral stones rose by 8% in Germany, 26% in France, and 15% in England. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis, Lithotripsy, Laser, Ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2024to 30 Jul 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 18 years
- Evidence of nephrolithiasis on presentation of a preoperative computer tomography (CT) scan not older than 6 months
- Minimum size of the kidney stones defined as \>10mm in the longest axis in the preoperative CT.
- Ability to read, write and speak German
- Women of childbearing age must have a negative serum pregnancy test at the start of the study.
- Submission of a personally signed and dated informed consent form stating that the subject has been informed of all relevant aspects of the study prior to any trial-related activity and that all information has been understood
Who cannot join
- Participation in another clinical trial for kidney stone removal in the last 6 months
- Subjects with gastrointestinal cancer who have not been in remission for at least 2 years
- Subjects with a single kidney, horseshoe kidney or other anatomical abnormalities that may increase the risk of surgery for the subject
- Subjects with untreated ureteral stenosis or renal stenosis and narrow ureteropelvic junction/ureterovesical junction
- Subjects with known impaired renal function from stage IV or known dialysis
- Subjects with chronic hydronephrosis not associated with nephrolithiasis
Show all 10Show fewer
- Subjects with the following known or suspected diseases: Coagulation disorders, untreated urinary tract infections, renal disease sepsis and marked prostatic hyperplasia
- Subjects with any other disease or condition that, in the opinion of the investigator, could interfere with the purpose of the study (e.g. bleeding that restricts vision in the kidney, problems in the renal tubular system)
- Breastfeeding or pregnant women
- Subjects who may be part of a vulnerable group (e.g. prisoners or developmentally delayed adults)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Straub, Doctor contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital rechts der Isar
Munich, Bavaria, 81675
Thomas Amiel, Doctor, 8941409678 ext. 0049, thomas.amiel@tum.de
Michael Straub, Doctor, 8941405531 ext. 0049
About this study
Official title: Standard of Care Ureterorenoscopy With Lithotripsy Versus in Combination With the Hydrogel Method for Kidney Stone Removal: An Open, Randomized, Monocentric Study
The incidence of kidney stones (urolithiasis) has surged in both developing and developed countries, affecting approximately 15% of the global population. From 2010 to 2019, diagnoses of kidney and ureteral stones rose by 8% in Germany, 26% in France, and 15% in England. Correspondingly, the number of surgical stone removal procedures increased by 3%, 38%, and 18%, respectively. Common treatments include extracorporeal shock wave lithotripsy (ESWL), ureterorenoscopy (URS) with lithotripsy, and percutaneous nephrolithotomy (PCNL).
URS, depending on stone size, has become a preferred method due to advancements in intraoperative imaging and laser technology. Despite these improvements, small fragments often remain post-intervention, leading to recurrent stones. Complete removal of all fragments is crucial to significantly reduce recurrence rates. Current literature suggests a high recurrence rate with residual fragments, impacting healthcare costs and patient quality of life.
Read more
A key objective in endourological research is optimizing the stone clearance rate. Techniques like coagulum lithotomy and the autologous blood clot technique have been developed to enhance residual stone removal after laser fragmentation. These methods benefit selected patients but are not widely adopted due to complications such as reduced intraoperative visibility and long coagulum formation times.
Recently, a two-component hydrogel system called mediNiK® (Purenum GmbH, Germany) was developed. This biocompatible gel can be applied through an endoscope after stone fragmentation and large fragment retrieval to embed smaller fragments and dust, forming a removable conglomerate. MediNiK® has demonstrated effectiveness in embedding and removing stone residues and is already in clinical use in Europe, showing potential for optimizing stone removal.
A multicenter study has assessed the safety and tolerability of mediNiK® in standard URS (Open, randomized, multicentre study to evaluate the safety, tolerability, and performance of mediNiK® compared to standard treatment in kidney stone removal - DRKS00030532). Results indicate the gel is safe and tolerable. However, further data from larger cohorts and comparisons with conventional URS are necessary before widespread adoption of mediNiK®.
Read the detailed description
The incidence of kidney stones (urolithiasis) has increased in both developing and developed countries, affecting around 15% of the world's population (1). Between 2010 and 2019, the diagnosis of kidney and ureteral stones in Germany, France and England increased by 8%, 26% and 15% respectively, while the number of surgical procedures to remove stones increased by 3%, 38% and 18% respectively (2). Common surgical treatments for kidney stones include extracorporeal shock wave lithotripsy (ESWL), ureterorenoscopy (URS) with lithotripsy and percutaneous nephrolithotomy (PCNL).
Depending on the size of the stone, URS has sometimes established itself as the method of choice, not least thanks to improved intraoperative imaging and the further development of laser technology. Despite these innovations, small fragments can remain in the kidney post-intervention, which in turn can lead to new stone formation (recurrent stones). From a medical point of view, complete removal of all fragments is essential in order to significantly reduce the recurrence rate of affected patients. According to the current literature, the recurrence rate in the sense of so-called secondary stone formation is estimated to be high in the case of residual fragments (3), associated with associated costs for the healthcare system and restrictions in the quality of life of the affected patients.
A major goal of endourological research in this area is therefore to optimize the stone clearance rate. Procedures such as coagulum lithotomy or the "autologous blood coagel technique" have been developed to improve the removal of residual stones after laser-guided fragmentation. Selected patients can benefit from these techniques, but their widespread use is limited, particularly due to the often associated deterioration in intraoperative visibility and the long waiting times until coagulum formation (4). For this reason, a two-component hydrogel system called mediNiK® (Purenum GmbH, Germany) was recently developed. This gel, consisting of two biocompatible components, can be applied via the inserted endoscope in a controlled manner and under visualization after completion of stone fragmentation and retrieval of large fragments in order to embed smaller stone fragments and dust. The resulting conglomerate can then be removed using conventional grasping forceps (5).
The hydrogel method with mediNik® has proven to be effective in embedding and removing stone residues (6). The system is already being used clinically in Europe and shows great potential for optimizing stone removal. A safety assessment in a multicenter study has already shown that the use of the gel is safe and tolerable in the context of standard URS. (Open, randomized, multicentre study to evaluate the safety, tolerability and performance of mediNiK® compared to standard treatment in the removal of kidney stones - DRKS00030532 - https://drks.de/search/de/trial/DRKS00030532.) However, before mediNik® can be used across the board, further data in a larger cohort and, in particular, a comparison with conventional URS are required.
The primary objective of this study is to compare the standard URS for the treatment of kidney stones without and with mediNik® with regard to the postoperative stone clearance rate. Further secondary endpoints are described in chapter 4. The results should provide the central basis for optimizing stone therapy at European centers and thereby improving medical care while optimizing costs.
- Conditions
- Nephrolithiasis, Lithotripsy, Laser, Ureteroscopy
- Being tested
- Standard of Care Ureterorenoscopy, Standard of Care Ureterorenoscopy with MediNiK
- Keywords
- Hydrogel, MediNiK, Hydrogel methode, Stone Free Rate, Zero Residual Fragments, URS, Dusting, Stone free, Thulium, Kidneystones
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care UreterorenoscopyProcedure or surgery
The patient provides written informed consent and is positioned in the supine position. After disinfection, sterile draping, and single-shot antibiotic administration a rigid cystoscopy is performed. Intubation of the ostium with a hydrophilic guidewire and placed into the renal pelvis under fluoroscopic control. After a semirigid URS, a working sheath is placed up to the Kidney. A flexible URS with lithotripsy with a Thulium lase is then performed to dust the stones. The fragments are retrieved for analysis. Finally, a double-J or mono-J stent and a transurethral catheter are placed.
Standard of Care Ureterorenoscopy with MediNiKProcedure or surgery
The patient provides written informed consent and is positioned in the supine position. After disinfection, sterile draping, and single-shot antibiotic administration a rigid cystoscopy is performed. Intubation of the ostium with a hydrophilic guidewire and placed into the renal pelvis under fluoroscopic control. After a semirigid URS, a working sheath is placed up to the Kidney. A flexible URS with lithotripsy with a Thulium lase is then performed to dust the stones. The fragments are retrieved for analysis. Application of MediNiK to embbed the residual stones in the hydrogel and extract it with a basket. Finally, a double-J or mono-J stent and a transurethral catheter are placed.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Ureterorenoscopy | Sham comparator | Arm A) Standard procedure ( URS) for the removal of kidney stones using URS Receives: Procedure: Standard of Care Ureterorenoscopy |
| Standard of Care Ureterorenoscopy with MediNik | Active comparator | Arm B) Standard procedure (URS) for the removal of kidney stones using URS in combination with the mediNiK® Receives: Procedure: Standard of Care Ureterorenoscopy with MediNiK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free Rate after URS
To answer the primary research question, a comparison of the SFR between the two surgical procedures is planned using the chi-square test. In order to be able to show a statistically significant difference with regard to the surgical procedures according to the current data situation (75 % vs. 95 %), a sample size of 120 was defined with a power of 80 % and a significance level of 0.025 (the significance correction is made due to the definition of two co-primary endpoints in relation to the definition of freedom from stones).
Measured: From enrollment to postoperative follow-up at 2 months.
Secondary outcomes (7)
Surgery Duration
- Duration of surgery (minutes, continuous): defined as the time from transurethral entry with the cystoscope to ureteral stent insertion in the affected kidney)
Measured: During the procedure
Laser duration
- Laser duration (minutes, continuous): defined as the time until the stone is sufficiently dusted
Measured: during the procedure
Basketing duration
- Basketing duration (minutes, continuous): defined as the time until the fragments are completely captured and removed
Measured: during the procedure
Complication
- Complication rates according to Clavien Dindo (I-IV); the type and number (%) are recorded
Measured: after the procedure up to 1 month
Subjective assessment of the operation by the surgeon
- Subjective assessment of the operation by the surgeon via questionnaire (Likert scales, 1-5): Difficulty 1 (easy) - 5 (very difficult) ,Stone-free 1(no stones) - 5 (2nd look necessary)
Measured: During the procedure
Cost
Costs (euros): defined as the costs of hospitalization, surgery, outpatient care and emergency presentation in euros per patient
Measured: From enrollment to postoperative follow-up at 12 months
Frequency of a stone-related event
Frequency of a stone-related event (defined as an event related to stone treatment, %): Repeat operation: DJ blocked (yes, no), completion of URS in case of residual stone (yes, no), repeat URS in case of stone recurrence (yes, no, side), DJ in case of new stone formation (yes, no, side, type), New stone formation: stone recurrence (yes, no, side), colic (yes, no, side), new imaging (yes, no, type)
Measured: From enrollment to postoperative follow-up at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Jul 2024
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Amiel, Technical University of Munich
- Investigators
- Michael Straub, Doctor, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469736
- Sponsor's protocol ID
- 2023-395-S-KK
- Status last verified
- Sep 2025
- First submitted
- 13 Jun 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Patient Data is only planned for this Study
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard of Care Ureterorenoscopy With Lithotripsy Versus in Combination With the Hydrogel Method for Kidney Stone Removal: An Open, Randomized, Monocentric Study
- ClinicalTrials.gov ID
- NCT06469736
- Acronym / sponsor ID
- 2023-395-S-KK
- Conditions
- Nephrolithiasis, Lithotripsy, Laser, Ureteroscopy
- Keywords
- Hydrogel, MediNiK, Hydrogel methode, Stone Free Rate, Zero Residual Fragments, URS, Dusting, Stone free
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 24 Jun 2024 (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 incidence of kidney stones (urolithiasis) has surged in both developing and developed countries, affecting approximately 15% of the global population. From 2010 to 2019, diagnoses of kidney and ureteral stones rose by 8% in Germany, 26% in France, and 15% in England. Correspondingly, the number of surgical stone removal procedures increased by 3%, 38%, and 18%, respectively. Common treatments include extracorporeal shock wave lithotripsy (ESWL), ureterorenoscopy (URS) with lithotripsy, and percutaneous nephrolithotomy (PCNL).
URS, depending on stone size, has become a preferred method due to advancements in intraoperative imaging and laser technology. Despite these improvements, small fragments often remain post-intervention, leading to recurrent stones. Complete removal of all fragments is crucial to significantly reduce recurrence rates. Current literature suggests a high recurrence rate with residual fragments, impacting healthcare costs and patient quality of life.
A key objective in endourological research is optimizing the stone clearance rate. Techniques like coagulum lithotomy and the autologous blood clot technique have been developed to enhance residual stone removal after laser fragmentation. These methods benefit selected patients but are not widely adopted due to complications such as reduced intraoperative visibility and long coagulum formation times.
Recently, a two-component hydrogel system called mediNiK® (Purenum GmbH, Germany) was developed. This biocompatible gel can be applied through an endoscope after stone fragmentation and large fragment retrieval to embed smaller fragments and dust, forming a removable conglomerate. MediNiK® has demonstrated effectiveness in embedding and removing stone residues and is already in clinical use in Europe, showing potential for optimizing stone removal.
A multicenter study has assessed the safety and tolerability of mediNiK® in standard URS (Open, randomized, multicentre study to evaluate the safety, tolerability, and performance of mediNiK® compared to standard treatment in kidney stone removal - DRKS00030532). Results indicate the gel is safe and tolerable. However, further data from larger cohorts and comparisons with conventional URS are necessary before widespread adoption of mediNiK®.
Detailed description
The incidence of kidney stones (urolithiasis) has increased in both developing and developed countries, affecting around 15% of the world's population (1). Between 2010 and 2019, the diagnosis of kidney and ureteral stones in Germany, France and England increased by 8%, 26% and 15% respectively, while the number of surgical procedures to remove stones increased by 3%, 38% and 18% respectively (2). Common surgical treatments for kidney stones include extracorporeal shock wave lithotripsy (ESWL), ureterorenoscopy (URS) with lithotripsy and percutaneous nephrolithotomy (PCNL).
Depending on the size of the stone, URS has sometimes established itself as the method of choice, not least thanks to improved intraoperative imaging and the further development of laser technology. Despite these innovations, small fragments can remain in the kidney post-intervention, which in turn can lead to new stone formation (recurrent stones). From a medical point of view, complete removal of all fragments is essential in order to significantly reduce the recurrence rate of affected patients. According to the current literature, the recurrence rate in the sense of so-called secondary stone formation is estimated to be high in the case of residual fragments (3), associated with associated costs for the healthcare system and restrictions in the quality of life of the affected patients.
A major goal of endourological research in this area is therefore to optimize the stone clearance rate. Procedures such as coagulum lithotomy or the "autologous blood coagel technique" have been developed to improve the removal of residual stones after laser-guided fragmentation. Selected patients can benefit from these techniques, but their widespread use is limited, particularly due to the often associated deterioration in intraoperative visibility and the long waiting times until coagulum formation (4). For this reason, a two-component hydrogel system called mediNiK® (Purenum GmbH, Germany) was recently developed. This gel, consisting of two biocompatible components, can be applied via the inserted endoscope in a controlled manner and under visualization after completion of stone fragmentation and retrieval of large fragments in order to embed smaller stone fragments and dust. The resulting conglomerate can then be removed using conventional grasping forceps (5).
The hydrogel method with mediNik® has proven to be effective in embedding and removing stone residues (6). The system is already being used clinically in Europe and shows great potential for optimizing stone removal. A safety assessment in a multicenter study has already shown that the use of the gel is safe and tolerable in the context of standard URS. (Open, randomized, multicentre study to evaluate the safety, tolerability and performance of mediNiK® compared to standard treatment in the removal of kidney stones - DRKS00030532 - https://drks.de/search/de/trial/DRKS00030532.) However, before mediNik® can be used across the board, further data in a larger cohort and, in particular, a comparison with conventional URS are required.
The primary objective of this study is to compare the standard URS for the treatment of kidney stones without and with mediNik® with regard to the postoperative stone clearance rate. Further secondary endpoints are described in chapter 4. The results should provide the central basis for optimizing stone therapy at European centers and thereby improving medical care while optimizing costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Ureterorenoscopy | Sham comparator | Procedure: Standard of Care UreterorenoscopyArm A) Standard procedure ( URS) for the removal of kidney stones using URS |
| Standard of Care Ureterorenoscopy with MediNik | Active comparator | Procedure: Standard of Care Ureterorenoscopy with MediNiKArm B) Standard procedure (URS) for the removal of kidney stones using URS in combination with the mediNiK® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged ≥ 18 years
- Evidence of nephrolithiasis on presentation of a preoperative computer tomography (CT) scan not older than 6 months
- Minimum size of the kidney stones defined as \>10mm in the longest axis in the preoperative CT.
- Ability to read, write and speak German
- Women of childbearing age must have a negative serum pregnancy test at the start of the study.
Key exclusion criteria (10 listed)
- Participation in another clinical trial for kidney stone removal in the last 6 months
- Subjects with gastrointestinal cancer who have not been in remission for at least 2 years
- Subjects with a single kidney, horseshoe kidney or other anatomical abnormalities that may increase the risk of surgery for the subject
- Subjects with untreated ureteral stenosis or renal stenosis and narrow ureteropelvic junction/ureterovesical junction
- Subjects with known impaired renal function from stage IV or known dialysis
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 |
|---|---|---|
| Standard of Care UreterorenoscopyThe patient provides written informed consent and is positioned in the supine position. After disinfection, sterile draping, and single-shot antibiotic administration a rigid cystoscopy is performed. Intubation of the ostium with a hydrophilic guidewire and placed into the renal pelvis under fluoroscopic control. After a semirigid URS, a working sheath is placed up to the Kidney. A flexible URS with lithotripsy with a Thulium lase is then performed to dust the stones. The fragments are retrieved for analysis. Finally, a double-J or mono-J stent and a transurethral catheter are placed. | Procedure or surgery | Standard of Care Ureterorenoscopy |
| Standard of Care Ureterorenoscopy with MediNiKThe patient provides written informed consent and is positioned in the supine position. After disinfection, sterile draping, and single-shot antibiotic administration a rigid cystoscopy is performed. Intubation of the ostium with a hydrophilic guidewire and placed into the renal pelvis under fluoroscopic control. After a semirigid URS, a working sheath is placed up to the Kidney. A flexible URS with lithotripsy with a Thulium lase is then performed to dust the stones. The fragments are retrieved for analysis. Application of MediNiK to embbed the residual stones in the hydrogel and extract it with a basket. Finally, a double-J or mono-J stent and a transurethral catheter are placed. | Procedure or surgery | Standard of Care Ureterorenoscopy with MediNik |
Primary outcome
Stone free Rate after URS
Time frame: From enrollment to postoperative follow-up at 2 months.
To answer the primary research question, a comparison of the SFR between the two surgical procedures is planned using the chi-square test. In order to be able to show a statistically significant difference with regard to the surgical procedures according to the current data situation (75 % vs. 95 %), a sample size of 120 was defined with a power of 80 % and a significance level of 0.025 (the significance correction is made due to the definition of two co-primary endpoints in relation to the definition of freedom from stones).
7 secondary outcomes
Surgery Duration
Time frame: During the procedure
Laser duration
Time frame: during the procedure
Basketing duration
Time frame: during the procedure
Complication
Time frame: after the procedure up to 1 month
Subjective assessment of the operation by the surgeon
Time frame: During the procedure
Cost
Time frame: From enrollment to postoperative follow-up at 12 months
Frequency of a stone-related event
Time frame: From enrollment to postoperative follow-up at 3 months.
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 9 Sep 2025.
- Individual participant dataSharing planned: No. The Patient Data is only planned for this Study
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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.
Michael Straub, Doctor contact
Michael Straub, Doctor principal investigator
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Nephrolithiasis and Lithotripsy, Laser, run by Technical University of Munich at 1 site in Germany.
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 6 inclusion and 10 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 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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 Thomas Amiel, doctor (8941409678 ext. 0049, thomas.amiel@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free Rate after URS (time frame: From enrollment to postoperative follow-up at 2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.