Renal StoneNCT04759599
Efficacy and Safety of Narrow Focus (F1) Versus Wide Focus (F3) of Shock Wave Lithotripsy (SWL) for Renal Calculi
A study testing Shock Wave Lithotripsy (SWL) in people with Renal Stone and Treatment Side Effects, run by Benha University at 1 site in Egypt.
Trial summary
This study aims to compare the narrow focus (F1) versus the wide focus (F3) in terms of the efficacy of Shock Wave Lithotripsy (SWL) in the management of renal calculi 1-2 cm and their injurious effect on the kidney. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Stone, Treatment Side Effects
- What is being tested?
- Shock Wave Lithotripsy (SWL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 30 Nov 2023
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (>18years old) with 1-2 cm single renal stone.
- Normal functioning kidney.
Who cannot join
- Pregnancy.
- Bleeding diatheses.
- Radiolucent stones.
- Radio-opaque stones with Hounsfield Unit (HU) > 1200
- Patients with a pacemaker.
- Active Urinary Tract Infection (UTI).
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- Severe skeletal malformations.
- Morbid obesity with Body Mass Index (BMI) ≥40 kg/m2.
- Renal artery aneurysm at the same site of the stone.
- Anatomical obstruction distal to the stone.
- Patients with renal impairment with serum creatinine > 1.2 mg/dL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Which is Better: Narrow vs. Wide Focus for Shock Wave Lithotripsy of Renal Stones
This study aims to compare the narrow focus (F1) versus the wide focus (F3) in terms of the efficacy of Shock Wave Lithotripsy (SWL) in the management of renal calculi 1-2 cm and their injurious effect on the kidney.
Read the detailed description
Recently, some Shock Wave Lithotripsy (SWL) devices have been announced in the market with a different focus points. One early experimental study found that stone disintegration is better with small focusing points than larger focusing points. Nevertheless, these findings, in terms of the efficacy of stone disintegration, need to be validated in-vivo. Furthermore, the effect of focal size on renal injury during SWL need to be studied as well. Therefore, the objectives of this study are to compare the effect of using the narrow focus of 2 mm (F1) versus the wide focus of 8 mm (F3) on the Stone Free Rate (SFR) following SWL for renal stones 1-2 cm and estimating renal injury effect of F1 vs. F3 by urinary renal injury markers such as neutrophil gelatinase-associated lipocalin (NGAL) for assessment of proximal and distal renal tubules injury \& Kidney Injury Molecule-1 (KIM-1) for assessment of proximal renal tubules injury).
The SWL device:
Lithotripter type: Piezo Lith3000 plus ( from Richard Wolf, Germany).
- Conditions
- Renal Stone, Treatment Side Effects
- Being tested
- Shock Wave Lithotripsy (SWL)
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock Wave Lithotripsy (SWL)Procedure or surgery
Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks or Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1 will undergo Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks Receives: Procedure: Shock Wave Lithotripsy (SWL) |
| Group 2 | Active comparator | Group 2 will undergo Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks Receives: Procedure: Shock Wave Lithotripsy (SWL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of efficacy of Shock Wave Lithotripsy (SWL) by calculation of the percentage (%) of stone free
Assessment of efficacy of Shock Wave Lithotripsy (SWL) and its success by calculation of stone free (%) following each session with a maximum of 3 Shock Wave Lithotripsy (SWL) sessions, 2 weeks a part, using pelvi-abdominal Ultrasound (US) and Kidney-Ureter-Bladder (KUB) and the presence of significant residual stone >4 mm will be considered "non-stone free" and the final stone free status (%) will be calculated at one month following the last session of Shock Wave Lithotripsy (SWL).
Shock Wave Lithotripsy (SWL) failure will be defined as failure to reach stone free status (%) one month after 3rd session.
Measured: 1 year
Secondary outcomes (6)
Assessment of the degree of renal injury using renal injury markers
Assessment of the degree of renal injury using renal injury markers as follow:
- Urine analysis for neutrophil gelatinase-associated lipocalin (NGAL) (ng/dL) \& Kidney Injury Molecule 1 (KIM-1) (ng/dL) will be measured measured with enzyme-linked immunosorbent assay (ELISA) method before, 2 hours after and 72 hours after the 1st Shock Wave Lithotripsy (SWL) session.
Measured: 1 year
Assessment of the presence of peri-renal hematoma
Assessment of the presence of peri-renal hematoma will be conducted as follow:
- Ultrasonography (US) will be done 24 hours after Shock Wave Lithotripsy (SWL) session to search for the presence of peri-renal hematoma and measure its size (cc).
Measured: 1 year
Assessment of the changes in renal cortical thickness
Changes in the renal cortical thickness will be assessed as follow:
- Ultrasonography (US) will be done before and after 6 months post Shock Wave Lithotripsy (SWL) for assessment of renal cortical thickness (mm) and the pre- and post-SWL measurements will be compared
Measured: 1 year
Measurement of the changes in the Renal Resistive Index (RRI)
Renal Resistive Index (RRI) will be measured in the arcuate arteries using the following formula "RRI can be calculated as (peak systolic velocity - end diastolic velocity)/peak systolic velocity" before and 24 hours after Shock Wave Lithotripsy (SWL) using Doppler Ultrasound and changes will be recorded
Measured: 1 year
assessment of pain during each SWL session
pain assessment during each SWL session; according to pain assessment scale using a validated 0 to 10 numeric pain rating scale.
Measured: 1 year
assessment of hematuria during and post SWL session
hematuria assessment during and after each SWL session; according to gross hematuria scale.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal StoneStudies 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
- evaluation of Efficacy and Safety of Narrow Focus (F1) Versus Wide Focus (F3) of Shock Wave Lithotripsy (SWL) for Renal Calculi
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser A. Noureldin, Benha University
- Investigators
- Yasser Noureldin, MD, PhD, Principal investigator, Benha UniversityAhmed Abdelbaky, MD, PhD, Study chair, Benha UniversityWalid Ibrahim, MD, PhD, Study director, Benha UniversityEzzat Elnahife, MD, Study director, Benha UniversitySalah El Hamshary, MD, PhD, Study director, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759599
- Sponsor's protocol ID
- MD 1-11-2020
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Turney BW, Reynard JM, Noble JG, Keoghane SR. Trends in urological stone disease. BJU Int. 2012 Apr;109(7):1082-7. doi: 10.1111/j.1464-410X.2011.10495.x. Epub 2011 Aug 26.
PubMed 21883851Connors BA, Evan AP, Blomgren PM, Handa RK, Willis LR, Gao S. Effect of initial shock wave voltage on shock wave lithotripsy-induced lesion size during step-wise voltage ramping. BJU Int. 2009 Jan;103(1):104-7. doi: 10.1111/j.1464-410X.2008.07922.x. Epub 2008 Aug 1.
PubMed 18680494Devarajan P. Biomarkers for the early detection of acute kidney injury. Curr Opin Pediatr. 2011 Apr;23(2):194-200. doi: 10.1097/MOP.0b013e328343f4dd.
PubMed 21252674Veser J, Jahrreiss V, Seitz C, Ozsoy M. The effect of focus size and intensity on stone fragmentation in SWL on a piezoelectric lithotripter. World J Urol. 2020 Oct;38(10):2645-2650. doi: 10.1007/s00345-019-03069-y. Epub 2020 Jan 10.
PubMed 31925550