Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age GroupNCT05293613
Extracorporeal Shock Wave Lithotripsy for Treatment of Large Pediatric Renal Pelvic Stone Burden More Than 2 cm
A study testing extracorporeal shock wave lithotripsy in people with Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group, run by Sohag University at 1 site in Egypt.
Trial summary
Extracorporeal shock wave lithotripsy (SWL) was first described for pediatric nephrolithiasis in 1986; SWL has been a mainstay of treatment for both renal and ureteral calculi in children . Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group
- What is being tested?
- extracorporeal shock wave lithotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Aug 2022
- 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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 1 year - 5 years old. ( as children younger than 5 years old has shorter skin to stone distance \& the option of endoscopic treatment of stones has is not feasible in this age group) Stone size: more than 2 cm \& less than 3.5 cm. Stone location: renal pelvis \& other calyces.
Who cannot join
- Age: less than 1 year \& more than 5 years old. Stone size: less than 2 cm \& more than 3.5 cm. Raised serum creatinine , coagulopathy. Distal urinary tract obstruction. Pulmonary or cardiac disease Anatomical abnormalities (UPJO, horses shoe kidney, ...)
Trial locations and contacts
1 site in 1 country.
About this study
Extracorporeal shock wave lithotripsy (SWL) was first described for pediatric nephrolithiasis in 1986; SWL has been a mainstay of treatment for both renal and ureteral calculi in children . SWL is currently regarded as first-line therapy for most renal and upper ureteral calculi <2.0 cm according to the EAU/ESPU guidelines . Meanwhile, the American Urological Association (AUA) considers SWL to be a first-line option along with URS for renal or ureteral calculi <2.0 cm, and a first-line option along with PNL for renal calculi >2.0 cm . The shock waves are better transmitted and spontaneous clearance of fragmented stones in pediatric kidneys is higher than adults' kidneys; thus, SWL treatment seems likely to be more successful in the pediatric population compared to the adult population .Younger age is associated with better stone clearance in children treated with SWL, and this is related mostly to increased ureteral compliance (shorter, more elastic and distensible) and shorter skin-to-stone distance .
- Conditions
- Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group
- Being tested
- extracorporeal shock wave lithotripsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shock wave lithotripsyDevice
shock wave transmited from the device through patient body towards the stone to disintegrate it
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | Not described Receives: Device: extracorporeal shock wave lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
degree of stone disintegration \& expulsion form pediatric patient after going through Extracorporeal shock wave lithotripsy for treatment of large pediatric renal pelvic stone burden more than 2 cm
Measured: 2 months
Secondary outcomes (1)
complications associated with pediatric SWL
Study complications associated with pediatric SWL with large stone burden > 2cm
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Apr 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age GroupStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khalaf Elsayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293613
- Sponsor's protocol ID
- Soh_Med_22_03_04
- Status last verified
- Aug 2022
- First submitted
- 15 Mar 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sultan S, Aba Umer S, Ahmed B, Naqvi SAA, Rizvi SAH. Update on Surgical Management of Pediatric Urolithiasis. Front Pediatr. 2019 Jul 3;7:252. doi: 10.3389/fped.2019.00252. eCollection 2019.
PubMed 31334207Tasian GE, Copelovitch L. Evaluation and medical management of kidney stones in children. J Urol. 2014 Nov;192(5):1329-36. doi: 10.1016/j.juro.2014.04.108. Epub 2014 Jun 21.
PubMed 24960469Gajengi AK, Wagaskar VG, Tanwar HV, Mhaske S, Patwardhan SK. Metabolic Evaluation in Paediatric Urolithiasis: A 4-Year Open Prospective Study. J Clin Diagn Res. 2016 Feb;10(2):PC04-6. doi: 10.7860/JCDR/2016/17265.7251. Epub 2016 Feb 1.
PubMed 27042515
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Lithotripsy for Treatment of Large Pediatric Renal Pelvic Stone Burden More Than 2 cm
- ClinicalTrials.gov ID
- NCT05293613
- Acronym / sponsor ID
- Soh_Med_22_03_04
- Conditions
- Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 24 Mar 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.
Extracorporeal shock wave lithotripsy (SWL) was first described for pediatric nephrolithiasis in 1986; SWL has been a mainstay of treatment for both renal and ureteral calculi in children . SWL is currently regarded as first-line therapy for most renal and upper ureteral calculi <2.0 cm according to the EAU/ESPU guidelines . Meanwhile, the American Urological Association (AUA) considers SWL to be a first-line option along with URS for renal or ureteral calculi <2.0 cm, and a first-line option along with PNL for renal calculi >2.0 cm . The shock waves are better transmitted and spontaneous clearance of fragmented stones in pediatric kidneys is higher than adults' kidneys; thus, SWL treatment seems likely to be more successful in the pediatric population compared to the adult population .Younger age is associated with better stone clearance in children treated with SWL, and this is related mostly to increased ureteral compliance (shorter, more elastic and distensible) and shorter skin-to-stone distance .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Device: extracorporeal shock wave lithotripsy |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age: 1 year - 5 years old. ( as children younger than 5 years old has shorter skin to stone distance \& the option of endoscopic treatment of stones has is not feasible in this age group) Stone size: more than 2 cm \& less than 3.5 cm. Stone location: renal pelvis \& other calyces.
Key exclusion criteria (1 listed)
- Age: less than 1 year \& more than 5 years old. Stone size: less than 2 cm \& more than 3.5 cm. Raised serum creatinine , coagulopathy. Distal urinary tract obstruction. Pulmonary or cardiac disease Anatomical abnormalities (UPJO, horses shoe 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 |
|---|---|---|
| extracorporeal shock wave lithotripsyshock wave transmited from the device through patient body towards the stone to disintegrate it | Device | Cases |
Primary outcome
stone free rate
Time frame: 2 months
degree of stone disintegration \& expulsion form pediatric patient after going through Extracorporeal shock wave lithotripsy for treatment of large pediatric renal pelvic stone burden more than 2 cm
1 secondary outcome
complications associated with pediatric SWL
Time frame: 2 months
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 1 Sep 2022.
- Background: PubMed 31334207Sultan S, Aba Umer S, Ahmed B, Naqvi SAA, Rizvi SAH. Update on Surgical Management of Pediatric Urolithiasis. Front Pediatr. 2019 Jul 3;7:252. doi: 10.3389/fped.2019.00252. eCollection 2019.
- Background: PubMed 24960469Tasian GE, Copelovitch L. Evaluation and medical management of kidney stones in children. J Urol. 2014 Nov;192(5):1329-36. doi: 10.1016/j.juro.2014.04.108. Epub 2014 Jun 21.
- Background: PubMed 27042515Gajengi AK, Wagaskar VG, Tanwar HV, Mhaske S, Patwardhan SK. Metabolic Evaluation in Paediatric Urolithiasis: A 4-Year Open Prospective Study. J Clin Diagn Res. 2016 Feb;10(2):PC04-6. doi: 10.7860/JCDR/2016/17265.7251. Epub 2016 Feb 1.
- Individual participant dataSharing planned: Yes
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 extracorporeal shock wave lithotripsy in people with Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group, run by Sohag 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 1 inclusion and 1 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 1 Sep 2022. 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: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05293613, which also lists 3 linked publications.
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 1 Sep 2022.