Renal CalculiNCT07334236
Energy Ramping Versus Fixed Dose ESWL
A study testing Extracorporeal shock wave lithotripsy in people with Renal Calculi, run by mohammed Abdelhafez at 1 site in Egypt.
Trial summary
This clinical trial compares two techniques of extracorporeal shock wave lithotripsy (ESWL) - energy ramping versus fixed dose - in adult patients with renal stones. The study aims to evaluate stone-free rates, retreatment needs, and safety outcomes across multiple clinical sites in Egypt. Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Calculi
- What is being tested?
- Extracorporeal shock wave lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2026to 1 Nov 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 Up to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults ≥18 years.
- Radiopaque renal or proximal/mid ureteral stone ≤20 mm.
- eGFR ≥60 mL/min/1.73 m².
- Fit for ESWL.
- Able to give informed consent and complete follow up.
Who cannot join
- • Pregnancy.
- Active, untreated UTI.
- Uncorrected bleeding disorder or anticoagulation that cannot be stopped.
- Prior ipsilateral renal surgery.
- Non radio-opaque stone without reliable imaging.
- Inability to tolerate ESWL or required anesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag university Hospital
Sohag, 82511
ahmed abdelhamed, professor, +201068056074, sharkawiahmed@yahoo.com
About this study
Official title: Energy Ramping Versus Fixed Dose ESWL on Stone-Free Rate (Comparative Study)
This clinical trial compares two techniques of extracorporeal shock wave lithotripsy (ESWL) - energy ramping versus fixed dose - in adult patients with renal stones. The study aims to evaluate stone-free rates, retreatment needs, and safety outcomes across multiple clinical sites in Egypt.
Read the detailed description
This multi-center, randomized controlled trial investigates the impact of energy ramping versus fixed-dose ESWL on stone clearance in patients with solitary renal calculi. Participants will be assigned to either a gradually increasing energy protocol or a constant energy protocol using standardized lithotripter settings. The primary outcome is stone-free rate at two weeks post-treatment, assessed via imaging. Secondary outcomes include retreatment rate, pain scores, adverse events, and procedure duration. The study is conducted under IRB approval from Sohag University and follows international ethical standards for human research.
- Conditions
- Renal Calculi
- Being tested
- Extracorporeal shock wave lithotripsy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave lithotripsyProcedure or surgery
Fixed Voltage (experimental): Subjects receive shock wave therapy at a constant energy level (e.g., 20-22 kV) for the entire duration of the session. Standard delivery includes approximately 3,000 shocks at a frequency of 60-90 shocks per minute.
Voltage Ramping (control): Subjects receive shock wave therapy starting at a low energy level (e.g., 6-10 kV) for an initial "priming" phase of 100-500 shocks. Energy is then escalated in predefined increments (e.g., 1-2 kV every 250-500 shocks) until reaching the target therapeutic voltage.
| Study group | Role | What they receive |
|---|---|---|
| fixed-dose ESWL | Active comparator | * Start therapeutic/high energy (e.g., 80-100% device max) from therapeutic phase.
* Total shocks: 2000-3000 adjusted by fragmentation progress and tolerance. Log shocks and cumulative energy. Receives: Procedure: Extracorporeal shock wave lithotripsy |
| escalating-dose ESWL | Experimental | * Stepwise escalation: increase energy every 500-1000 shocks (example: 20% → 40% → 60% → 80-100%) until therapeutic energy reached.
* Total shocks: 2000-3000 adjusted by fragmentation progress and tolerance. Log shocks per step and cumulative energy. Receives: Procedure: Extracorporeal shock wave lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Proportion of participants achieving complete stone clearance as confirmed by imaging (ultrasound or CT).
Measured: 4 weeks
Secondary outcomes (1)
Number of ESWL sessions to achieve SFR.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start3 Jan 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CalculiStudies 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 Parallel Assignment Randomized, two-arm parallel assignment comparing energy-ramping ESWL versus fixed-dose ESWL; participants randomized 1:1. Treatment allocation is stratified by stone size (\<10 mm vs ≥10 mm). Primary outcomes assessed at 3 months post-treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- mohammed Abdelhafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mohammed Abdelhafez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334236
- Sponsor's protocol ID
- Soh-med--25-11-18MS
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Ramping Versus Fixed Dose ESWL on Stone-Free Rate (Comparative Study)
- ClinicalTrials.gov ID
- NCT07334236
- Acronym / sponsor ID
- Soh-med--25-11-18MS
- Conditions
- Renal Calculi
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- mohammed AbdelhafezUniversity, hospital or other
- Study start
- 3 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 12 Jan 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.
This clinical trial compares two techniques of extracorporeal shock wave lithotripsy (ESWL) - energy ramping versus fixed dose - in adult patients with renal stones. The study aims to evaluate stone-free rates, retreatment needs, and safety outcomes across multiple clinical sites in Egypt.
Detailed description
This multi-center, randomized controlled trial investigates the impact of energy ramping versus fixed-dose ESWL on stone clearance in patients with solitary renal calculi. Participants will be assigned to either a gradually increasing energy protocol or a constant energy protocol using standardized lithotripter settings. The primary outcome is stone-free rate at two weeks post-treatment, assessed via imaging. Secondary outcomes include retreatment rate, pain scores, adverse events, and procedure duration. The study is conducted under IRB approval from Sohag University and follows international ethical standards for human research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Parallel Assignment Randomized, two-arm parallel assignment comparing energy-ramping ESWL versus fixed-dose ESWL; participants randomized 1:1. Treatment allocation is stratified by stone size (<10 mm vs ≥10 mm). Primary outcomes assessed at 3 months post-treatment.
| Arm | Type | Receives |
|---|---|---|
| fixed-dose ESWL | Active comparator | Procedure: Extracorporeal shock wave lithotripsy* Start therapeutic/high energy (e.g., 80-100% device max) from therapeutic phase. * Total shocks: 2000-3000 adjusted by fragmentation progress and tolerance. Log shocks and cumulative energy. |
| escalating-dose ESWL | Experimental | Procedure: Extracorporeal shock wave lithotripsy* Stepwise escalation: increase energy every 500-1000 shocks (example: 20% → 40% → 60% → 80-100%) until therapeutic energy reached. * Total shocks: 2000-3000 adjusted by fragmentation progress and tolerance. Log shocks per step and cumulative energy. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥18 years.
- Radiopaque renal or proximal/mid ureteral stone ≤20 mm.
- eGFR ≥60 mL/min/1.73 m².
- Fit for ESWL.
- Able to give informed consent and complete follow up.
Key exclusion criteria (6 listed)
- • Pregnancy.
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 |
|---|---|---|
| Extracorporeal shock wave lithotripsyFixed Voltage (experimental): Subjects receive shock wave therapy at a constant energy level (e.g., 20-22 kV) for the entire duration of the session. Standard delivery includes approximately 3,000 shocks at a frequency of 60-90 shocks per minute. Voltage Ramping (control): Subjects receive shock wave therapy starting at a low energy level (e.g., 6-10 kV) for an initial "priming" phase of 100-500 shocks. Energy is then escalated in predefined increments (e.g., 1-2 kV every 250-500 shocks) until reaching the target therapeutic voltage. | Procedure or surgery | escalating-dose ESWL, fixed-dose ESWL |
Primary outcome
Stone free rate
Time frame: 4 weeks
Proportion of participants achieving complete stone clearance as confirmed by imaging (ultrasound or CT).
1 secondary outcome
Number of ESWL sessions to achieve SFR.
Time frame: 4 weeks
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 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave lithotripsy in people with Renal Calculi, run by mohammed Abdelhafez 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 5 inclusion and 6 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 12 Jan 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?
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 mohammed A Abdelhafez (+201143548707, 3elwa97@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: 4 weeks). 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 12 Jan 2026.