Stone, KidneyNCT05413603
Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization
A study testing ultrasonic focus Shock wave lithotripsy and fluoroscopic focus Shock wave lithotripsy in people with Stone, Kidney and Child, Only, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Stone, Kidney, Child, Only
- What is being tested?
- ultrasonic focus Shock wave lithotripsy and fluoroscopic focus 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
- 25 May 2022to 30 May 2023
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm
Who cannot join
- Previous percutaneous nephrolithotripsy at the same side.
- Previous renal exploration for stones at the same side.
- Positive urinary culture.
- Calyceal stones
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology department - faculty of medicine, South Valley university
Qina
About this study
Official title: Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization for Pediatric Renal Stones.
Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades.
Read the detailed description
Pediatric stone disease is considered endemic in developing nations including Turkey, Pakistan, and eastern countries. The introduction of SWL by Chaussy et al. in the early 1980s revolutionized the management of upper urinary tract calculus disease.
Reports of successful SWL in children were first published in 1986; then several reports showed safety, and stone-free rates comparable with those of adults. For successful SWL, accurate localization of the shock waves is performed by ultrasound (US) or fluoroscope (FS) to fully focus the shock waves on the stone
- Conditions
- Stone, Kidney, Child, Only
- Being tested
- ultrasonic focus Shock wave lithotripsy, fluoroscopic focus Shock wave lithotripsy
- Keywords
- pediatric renal stones, ultrasound shock waves, fluoroscope.
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonic focus Shock wave lithotripsyProcedure or surgery
successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone
fluoroscopic focus Shock wave lithotripsyProcedure or surgery
successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone
| Study group | Role | What they receive |
|---|---|---|
| fluoroscopic focus Shock wave lithotripsy | Active comparator | Shock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone Receives: Procedure: ultrasonic focus Shock wave lithotripsy; Procedure: fluoroscopic focus Shock wave lithotripsy |
| ultrasonic focus Shock wave lithotripsy | Active comparator | Shock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone Receives: Procedure: ultrasonic focus Shock wave lithotripsy; Procedure: fluoroscopic focus Shock wave lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lithotripsy or nephrolithotripsy by Shock waves
Incidence of success of Nephrolithotripsy by using Fluoroscopic shock waves or Ultrasonic shock waves in pediatric renal pelvic stones.
Measured: from baseline to 3 months after the Lithotripsy date.
Secondary outcomes (1)
Complications of shockwave lithotripsy
to evaluate postoperative complications of the lithotripsy as :
- Incidence of Hematuria
- Incidence of Fever
- Incidence of UTI
- Serum creatinine level in blood
- Rate of hydronephrosis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start25 May 2022
- Primary completion25 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stone, KidneyStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmoud Moubarak, Resident, Principal investigator, Urology department - faculty of medicine, South Valley university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413603
- Sponsor's protocol ID
- Mahmoud Moubarak
- Status last verified
- Jul 2023
- First submitted
- 19 May 2022
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization for Pediatric Renal Stones.
- ClinicalTrials.gov ID
- NCT05413603
- Acronym / sponsor ID
- Mahmoud Moubarak
- Conditions
- Stone, Kidney, Child, Only
- Keywords
- pediatric renal stones, ultrasound shock waves, fluoroscope.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 25 May 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 10 Jun 2022 (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.
Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades.
Detailed description
Pediatric stone disease is considered endemic in developing nations including Turkey, Pakistan, and eastern countries. The introduction of SWL by Chaussy et al. in the early 1980s revolutionized the management of upper urinary tract calculus disease.
Reports of successful SWL in children were first published in 1986; then several reports showed safety, and stone-free rates comparable with those of adults. For successful SWL, accurate localization of the shock waves is performed by ultrasound (US) or fluoroscope (FS) to fully focus the shock waves on the stone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluoroscopic focus Shock wave lithotripsy | Active comparator | Procedure: ultrasonic focus Shock wave lithotripsy, Procedure: fluoroscopic focus Shock wave lithotripsyShock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone |
| ultrasonic focus Shock wave lithotripsy | Active comparator | Procedure: ultrasonic focus Shock wave lithotripsy, Procedure: fluoroscopic focus Shock wave lithotripsyShock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm
Key exclusion criteria (4 listed)
- Previous percutaneous nephrolithotripsy at the same side.
- Previous renal exploration for stones at the same side.
- Positive urinary culture.
- Calyceal stones
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 |
|---|---|---|
| ultrasonic focus Shock wave lithotripsysuccessful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone | Procedure or surgery | fluoroscopic focus Shock wave lithotripsy, ultrasonic focus Shock wave lithotripsy |
| fluoroscopic focus Shock wave lithotripsysuccessful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone | Procedure or surgery | fluoroscopic focus Shock wave lithotripsy, ultrasonic focus Shock wave lithotripsy |
Primary outcome
Lithotripsy or nephrolithotripsy by Shock waves
Time frame: from baseline to 3 months after the Lithotripsy date.
Incidence of success of Nephrolithotripsy by using Fluoroscopic shock waves or Ultrasonic shock waves in pediatric renal pelvic stones.
1 secondary outcome
Complications of shockwave lithotripsy
Time frame: through study completion, an average of 1 year
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 10 Jul 2023.
- 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. This study is not recruiting at the moment.
Mahmoud Moubarak, Resident principal investigator
Urology department - faculty of medicine, South Valley university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonic focus Shock wave lithotripsy and fluoroscopic focus Shock wave lithotripsy in people with Stone, Kidney and Child, Only, run by Egymedicalpedia 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 1 inclusion and 4 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 10 Jul 2023. 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?
Lithotripsy or nephrolithotripsy by Shock waves (time frame: from baseline to 3 months after the Lithotripsy date.). 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 10 Jul 2023.