UrolithiasisNCT07445646
Efficacy of Different Modalities on Management of Renal Hard Stones
A study testing Lithotripsy using Flexible ureteroscope, Extracorporeal shock wave lithotripsy (ESWL) and holmium laser lithotripsy using Karl® Storz MIP in people with Urolithiasis and Stone, Kidney, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The study has been conducted in Urology department at Kafrelsheikh University Hospital between Feburary 2021 to December 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Stone, Kidney
- What is being tested?
- Lithotripsy using Flexible ureteroscope, Extracorporeal shock wave lithotripsy (ESWL) and holmium laser lithotripsy using Karl® Storz MIP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 30 Dec 2025
- 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
- Adult patient older than 18 years.
- single renal stone.
- medium sized Stone up to 2.0 cm .
- Do novo
- Stone in plevicalyceal except lower calyceal stone
- Hard stone
Who cannot join
- multiple renal stones
- Stone in lower calyceal stone
- stone size > 2 cm
- age group < 18
- solitary kidney
- Patients with BMI > 40 kg/m2
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- bleeding disorders
- anatomical renal abnormalities
- Obstruction distal to the stone.
- Musculoskeletal deformities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Outcomes of FURS, ESWL and Mini-PCNL for Non-Lower Pole Hard Renal Stones: A Prospective Randomized Study.
The study has been conducted in Urology department at Kafrelsheikh University Hospital between Feburary 2021 to December 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) while, Group B : extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) .Group C : Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.
- Conditions
- Urolithiasis, Stone, Kidney
- Being tested
- Lithotripsy using Flexible ureteroscope, Extracorporeal shock wave lithotripsy (ESWL), holmium laser lithotripsy using Karl® Storz MIP
- Medical subject headings
- Urolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithotripsy using Flexible ureteroscopeProcedure or surgery
using Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate
Extracorporeal shock wave lithotripsy (ESWL)Procedure or surgery
using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate
holmium laser lithotripsy using Karl® Storz MIPProcedure or surgery
using holmium laser lithotripsy using Karl® Storz MIP set to get high stone clearance rate
| Study group | Role | What they receive |
|---|---|---|
| Group A :Flexible ureteroscope group | Active comparator | Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) Receives: Procedure: Lithotripsy using Flexible ureteroscope |
| Group B : extracorporeal shock wave lithotripsy (ESWL) group | Active comparator | extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) Receives: Procedure: Extracorporeal shock wave lithotripsy (ESWL) |
| Group C : Mini perc group | Active comparator | Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set. Receives: Procedure: holmium laser lithotripsy using Karl® Storz MIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
no stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up two weeks.
Measured: two weeks from primary procedure
Secondary outcomes (3)
ssess operative time
assess operative time.in minutes
Measured: during the procedure
Radiation time
Time of patient exposure for radiation in minutes
Measured: during the procedure
Post operative complication
Complication may occur post operative complication like fever, sever pain
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Feb 2023
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
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.
- More trials run by Kafrelsheikh UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Abdelhalim Elsayed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445646
- Sponsor's protocol ID
- Renal Stones
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes of FURS, ESWL and Mini-PCNL for Non-Lower Pole Hard Renal Stones: A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT07445646
- Acronym / sponsor ID
- Renal Stones
- Conditions
- Urolithiasis, Stone, Kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 3 Mar 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.
The study has been conducted in Urology department at Kafrelsheikh University Hospital between Feburary 2021 to December 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) while, Group B : extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) .Group C : Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A :Flexible ureteroscope group | Active comparator | Procedure: Lithotripsy using Flexible ureteroscopeFlexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) |
| Group B : extracorporeal shock wave lithotripsy (ESWL) group | Active comparator | Procedure: Extracorporeal shock wave lithotripsy (ESWL)extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) |
| Group C : Mini perc group | Active comparator | Procedure: holmium laser lithotripsy using Karl® Storz MIPMini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient older than 18 years.
- single renal stone.
- medium sized Stone up to 2.0 cm .
- Do novo
- Stone in plevicalyceal except lower calyceal stone
Key exclusion criteria (10 listed)
- multiple renal stones
- Stone in lower calyceal stone
- stone size > 2 cm
- age group < 18
- solitary kidney
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 |
|---|---|---|
| Lithotripsy using Flexible ureteroscopeusing Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate | Procedure or surgery | Group A :Flexible ureteroscope group |
| Extracorporeal shock wave lithotripsy (ESWL)using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate | Procedure or surgery | Group B : extracorporeal shock wave lithotripsy (ESWL) group |
| holmium laser lithotripsy using Karl® Storz MIPusing holmium laser lithotripsy using Karl® Storz MIP set to get high stone clearance rate | Procedure or surgery | Group C : Mini perc group |
Primary outcome
stone free rate
Time frame: two weeks from primary procedure
no stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up two weeks.
3 secondary outcomes
ssess operative time
Time frame: during the procedure
Radiation time
Time frame: during the procedure
Post operative complication
Time frame: Up to 48 hours
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 23 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lithotripsy using Flexible ureteroscope, Extracorporeal shock wave lithotripsy (ESWL) and holmium laser lithotripsy using Karl® Storz MIP in people with Urolithiasis and Stone, Kidney, run by Kafrelsheikh University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 23 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 1 site in Egypt. 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 rate (time frame: two weeks from primary procedure). 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 23 Oct 2026.