Kidney StoneNCT05995652
Can Shear Wave Elastography Predict the Success of ESWL: a Prospective Study
An observational study of Kidney Stone, run by Abdelrahim Elsherbiny at 1 site in Egypt.
Trial summary
Can Shear Wave Elastography predict the success of Shock-Wave Lithotripsy used in renal stones treatment ? A prospective study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- What is being tested?
- elastography
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2023to 31 Jan 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1 gp of 50 pts will be subjected to ESWL and will be divided into 2 other gps success and failed
Who may be able to join
- Patients more than 18 years
- With single radiopaque renal stone
- Ranging in size from (1-1,5 cm) for ESWL.
Who cannot join
- Any urological abnormal anatomy
- Lower calyceal stone more than 1cm
- Impaired renal functions
- Uncorrected coagulopathy.
- Active UTI Pregnancy Single kidney Multiple stones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Shear Wave Elastography Predict the Success of Shock-Wave Lithotripsy Used in Renal Stones Treatment: a Prospective Study
Can Shear Wave Elastography predict the success of Shock-Wave Lithotripsy used in renal stones treatment ? A prospective study
Read the detailed description
Extracorporeal shock-wave lithotripsy (ESWL) is the noninvasive treatment method that is recommended as the first choice in the treatment of small and medium sized renal stones and proximal ureteral stones.
This study is a trial to determine the predictive role of shear wave elastography in the success of ESWL management of kidney stones.
- Conditions
- Kidney Stone
- Being tested
- elastography
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastographyProcedure or surgery
elastography
| Study group | Role | What they receive |
|---|---|---|
| ESWL sucess and failed gps | post ESWL 50 pt large gp will be devided into sucess gp and failed gp Receives: Procedure: elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
post ESWL
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start30 Aug 2023
- Primary completion21 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdelrahim Elsherbiny
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrahim Elsherbiny, Ain Shams University
- Investigators
- tarek elzayat, prof.dr., Study chair, AinShams
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995652
- Sponsor's protocol ID
- Abdelrahim Elsherbiny
- Status last verified
- Feb 2024
- First submitted
- 9 Aug 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Shear Wave Elastography Predict the Success of Shock-Wave Lithotripsy Used in Renal Stones Treatment: a Prospective Study
- ClinicalTrials.gov ID
- NCT05995652
- Acronym / sponsor ID
- Abdelrahim Elsherbiny
- Conditions
- Kidney Stone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Abdelrahim ElsherbinyUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 21 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 16 Aug 2023 (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.
Can Shear Wave Elastography predict the success of Shock-Wave Lithotripsy used in renal stones treatment ? A prospective study
Detailed description
Extracorporeal shock-wave lithotripsy (ESWL) is the noninvasive treatment method that is recommended as the first choice in the treatment of small and medium sized renal stones and proximal ureteral stones.
This study is a trial to determine the predictive role of shear wave elastography in the success of ESWL management of kidney stones.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESWL sucess and failed gps | – | Procedure: elastographypost ESWL 50 pt large gp will be devided into sucess gp and failed gp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1 gp of 50 pts will be subjected to ESWL and will be divided into 2 other gps success and failed
Key inclusion criteria (3 listed)
- Patients more than 18 years
- With single radiopaque renal stone
- Ranging in size from (1-1,5 cm) for ESWL.
Key exclusion criteria (5 listed)
- Any urological abnormal anatomy
- Lower calyceal stone more than 1cm
- Impaired renal functions
- Uncorrected coagulopathy.
- Active UTI Pregnancy Single kidney Multiple 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 |
|---|---|---|
| elastographyelastography | Procedure or surgery | ESWL sucess and failed gps |
Primary outcome
stone free rate
Time frame: 1 month
post ESWL
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 5 Feb 2024.
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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.
tarek elzayat, prof.dr. study chair
AinShams
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone, run by Abdelrahim Elsherbiny 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 3 inclusion and 5 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 5 Feb 2024. 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: 1 month). 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 5 Feb 2024.