Renal StonesNCT06720311
Management of Medium Sized Renal Stones
A study testing Modified Tubeless Super-Mini Percutaneous Nephrolithotomy, Flexible Ureterorenoscopy and Shockwave Lithotripsy in people with Renal Stones, run by Assiut University.
Trial summary
Urinary stone disease is a common urological condition that affects millions of people worldwide, often leading to significant morbidity and healthcare costs. Medium-sized renal stones, typically defined as stones measuring 1 to 2 cm in diameter, pose a particular challenge in management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stones
- What is being tested?
- Modified Tubeless Super-Mini Percutaneous Nephrolithotomy, Flexible Ureterorenoscopy and Shockwave Lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2027
- 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
- Adult patients (≥ 18 years old)
- Single renal stones 10-20 mm in longest dimension
Who cannot join
- Previous upper urinary tract exploration in ipsilateral side.
- Patients with JJ stent in ipsilateral side.
- Absolute contraindications to SWL
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between Modified Tubeless Super-Mini Percutaneous Nephrolithotomy, Flexible Ureterorenoscopy and Shockwave Lithotripsy for Treatment of Medium-sized Renal Stones: a Randomized Study
Urinary stone disease is a common urological condition that affects millions of people worldwide, often leading to significant morbidity and healthcare costs. Medium-sized renal stones, typically defined as stones measuring 1 to 2 cm in diameter, pose a particular challenge in management. These stones are large enough to potentially cause significant obstruction and symptoms, yet their size and location make selecting an optimal treatment modality crucial for achieving favorable outcomes with minimal complications.
Historically, open surgery was the primary intervention for large or complex stones. However, the advent of minimally invasive techniques has revolutionized stone management, allowing for more effective and patient-friendly approaches. Among these, Super-mini percutaneous nephrolithotomy (SMP), flexible uretero-renoscopy (F-URS), and shock wave lithotripsy (SWL) have emerged as minimally invasive modalities for managing medium-sized renal stones.
This study aims to evaluate the outcomes; safety, efficacy, and complications associated with SMP versus F-URS Versus SWL in the management of reanl stones 10-20 mm in diameter.
Read the detailed description
- SWL All cases will be treated as day care procedures, under analgesia without any anesthesia. Dornier MedTech (Compact Delta II), an electromagnetic shock wave lithotripter will be used. Patients will be treated in supine position and the calculus will be localized by using X-ray or Ultrasound. All sessions will be performed by a single technician under the supervision of a urology consultant. Shock waves will be delivered at the rate of 60-80 per minute with a maximum of 2500 shocks per session of treatment. Session will be started with low energy waves and gradually increased according to patient tolerability. A maximum of 2 sessions spaced two weeks apart. All patients will be advised to drink lots of fluids and maintain active lifestyle and skipping exercises if possible. Prior to every sitting an X-ray KUB will be obtained to see for the state of clearance of stone.
- Tubeless Super mini-PCNL (SMP) Modified technique will be performed in prone position using 14 Fr Amplatz sheath with the use of Karl Stroz semi rigid ureteroscope, Holmium Laser. Lithotripsy will be achieved by means of Holmium laser fiber 365 um. Ureteric catheter will be removed after 24 hours unless there is indications for JJ stent insertion ( eg. Only functioning kidney, perforation, etc)
- F-URS A sensor guide wire was placed into the renal pelvis via rigid ureteroscope. A 11-13 Fr access sheath will be placed into the ureter, if possible. After ureteral access was obtained, a 8 Fr flexible ureteroscope will be used for the stone treatment. The stones disintegration by holmium laser fibers. At the end of the procedure, a ureteral stent (JJ stent or Ureteric catheter) will be inserted
- Conditions
- Renal Stones
- Being tested
- Modified Tubeless Super-Mini Percutaneous Nephrolithotomy, Flexible Ureterorenoscopy, Shockwave Lithotripsy
- Keywords
- Medium sized renal stones
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Tubeless Super-Mini Percutaneous NephrolithotomyProcedure or surgery
Modified Tubeless Super-Mini Percutaneous Nephrolithotomy
Flexible UreterorenoscopyProcedure or surgery
Flexible Ureterorenoscopy
Shockwave LithotripsyProcedure or surgery
Shockwave Lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| Modified Tubeless Super-Mini Percutaneous Nephrolithotomy | Active comparator | Not described Receives: Procedure: Modified Tubeless Super-Mini Percutaneous Nephrolithotomy |
| Flexible Ureterorenoscopy | Active comparator | Not described Receives: Procedure: Flexible Ureterorenoscopy |
| Shockwave Lithotripsy | Active comparator | Not described Receives: Procedure: Shockwave Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
- SFR (by MSCT KUB) a patient is considered stone-free if the remaining fragments are less than 3 mm in size after 3 months of the procedure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hamdan Gameel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720311
- Sponsor's protocol ID
- AssiutU AGameel
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Modified Tubeless Super-Mini Percutaneous Nephrolithotomy, Flexible Ureterorenoscopy and Shockwave Lithotripsy for Treatment of Medium-sized Renal Stones: a Randomized Study
- ClinicalTrials.gov ID
- NCT06720311
- Acronym / sponsor ID
- AssiutU AGameel
- Conditions
- Renal Stones
- Keywords
- Medium sized renal stones
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Dec 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.
Urinary stone disease is a common urological condition that affects millions of people worldwide, often leading to significant morbidity and healthcare costs. Medium-sized renal stones, typically defined as stones measuring 1 to 2 cm in diameter, pose a particular challenge in management. These stones are large enough to potentially cause significant obstruction and symptoms, yet their size and location make selecting an optimal treatment modality crucial for achieving favorable outcomes with minimal complications.
Historically, open surgery was the primary intervention for large or complex stones. However, the advent of minimally invasive techniques has revolutionized stone management, allowing for more effective and patient-friendly approaches. Among these, Super-mini percutaneous nephrolithotomy (SMP), flexible uretero-renoscopy (F-URS), and shock wave lithotripsy (SWL) have emerged as minimally invasive modalities for managing medium-sized renal stones.
This study aims to evaluate the outcomes; safety, efficacy, and complications associated with SMP versus F-URS Versus SWL in the management of reanl stones 10-20 mm in diameter.
Detailed description
- SWL All cases will be treated as day care procedures, under analgesia without any anesthesia. Dornier MedTech (Compact Delta II), an electromagnetic shock wave lithotripter will be used. Patients will be treated in supine position and the calculus will be localized by using X-ray or Ultrasound. All sessions will be performed by a single technician under the supervision of a urology consultant. Shock waves will be delivered at the rate of 60-80 per minute with a maximum of 2500 shocks per session of treatment. Session will be started with low energy waves and gradually increased according to patient tolerability. A maximum of 2 sessions spaced two weeks apart. All patients will be advised to drink lots of fluids and maintain active lifestyle and skipping exercises if possible. Prior to every sitting an X-ray KUB will be obtained to see for the state of clearance of stone.
- Tubeless Super mini-PCNL (SMP) Modified technique will be performed in prone position using 14 Fr Amplatz sheath with the use of Karl Stroz semi rigid ureteroscope, Holmium Laser. Lithotripsy will be achieved by means of Holmium laser fiber 365 um. Ureteric catheter will be removed after 24 hours unless there is indications for JJ stent insertion ( eg. Only functioning kidney, perforation, etc)
- F-URS A sensor guide wire was placed into the renal pelvis via rigid ureteroscope. A 11-13 Fr access sheath will be placed into the ureter, if possible. After ureteral access was obtained, a 8 Fr flexible ureteroscope will be used for the stone treatment. The stones disintegration by holmium laser fibers. At the end of the procedure, a ureteral stent (JJ stent or Ureteric catheter) will be inserted
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Modified Tubeless Super-Mini Percutaneous Nephrolithotomy | Active comparator | Procedure: Modified Tubeless Super-Mini Percutaneous Nephrolithotomy |
| Flexible Ureterorenoscopy | Active comparator | Procedure: Flexible Ureterorenoscopy |
| Shockwave Lithotripsy | Active comparator | Procedure: Shockwave Lithotripsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (≥ 18 years old)
- Single renal stones 10-20 mm in longest dimension
Key exclusion criteria (3 listed)
- Previous upper urinary tract exploration in ipsilateral side.
- Patients with JJ stent in ipsilateral side.
- Absolute contraindications to SWL
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 |
|---|---|---|
| Modified Tubeless Super-Mini Percutaneous NephrolithotomyModified Tubeless Super-Mini Percutaneous Nephrolithotomy | Procedure or surgery | Modified Tubeless Super-Mini Percutaneous Nephrolithotomy |
| Flexible UreterorenoscopyFlexible Ureterorenoscopy | Procedure or surgery | Flexible Ureterorenoscopy |
| Shockwave LithotripsyShockwave Lithotripsy | Procedure or surgery | Shockwave Lithotripsy |
Primary outcome
Stone free rate
Time frame: 3 months
1. SFR (by MSCT KUB) a patient is considered stone-free if the remaining fragments are less than 3 mm in size after 3 months of the procedure
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 18 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Renal Stones
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
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.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Tubeless Super-Mini Percutaneous Nephrolithotomy, Flexible Ureterorenoscopy and Shockwave Lithotripsy in people with Renal Stones, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hamdan (+201020959949, ahmedhj111@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate (time frame: 3 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 18 Dec 2024.