Kidney StonesNCT07585435
Acoustic Impedance Matching in ESWL Coupling
A study testing Hypotonic degassed water coupling, Isotonic (0.9% NaCl) coupling and Hypertonic (3% NaCl) coupling in people with Kidney Stones, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effect of different salt concentrations (tonicity) in the coupling fluid used during Extracorporeal Shock Wave Lithotripsy (ESWL). The study compares three types of coupling fluids: hypotonic (degassed water), isotonic (0.9% NaCl), and hypertonic (3% NaCl) solutions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Hypotonic degassed water coupling, Isotonic (0.9% NaCl) coupling and Hypertonic (3% NaCl) coupling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 28 Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with kidney stones measuring 5-20 mm.
- Patients scheduled for ESWL treatment.
- Age 18 and older
Who cannot join
- Pregnancy.
- Uncorrected bleeding disorders.
- Active urinary tract infection.
- Anatomical abnormalities preventing ESWL.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Konya City Hospital
Konya, 42020
About this study
Official title: Acoustic Impedance Matching in ESWL: A Comparative Analysis of Hypotonic, Isotonic and Hypertonic Coupling Fluids
The purpose of this study is to investigate the effect of different salt concentrations (tonicity) in the coupling fluid used during Extracorporeal Shock Wave Lithotripsy (ESWL). The study compares three types of coupling fluids: hypotonic (degassed water), isotonic (0.9% NaCl), and hypertonic (3% NaCl) solutions. Researchers aim to determine which solution provides the best stone fragmentation success while minimizing procedure-related pain and skin complications.
- Conditions
- Kidney Stones
- Being tested
- Hypotonic degassed water coupling, Isotonic (0.9% NaCl) coupling, Hypertonic (3% NaCl) coupling
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotonic degassed water couplingProcedure or surgery
Hypotonic degassed water was used as the coupling fluid during the ESWL procedure.
Isotonic (0.9% NaCl) couplingProcedure or surgery
0.9% NaCl (isotonic) solution was used as the coupling fluid during the ESWL procedure.
Hypertonic (3% NaCl) couplingProcedure or surgery
3% NaCl (hypertonic) solution was used as the coupling fluid during the ESWL procedure.
| Study group | Role | What they receive |
|---|---|---|
| Hypotonic Group | Active comparator | Patients in this group received extracorporeal shock wave lithotripsy (ESWL) using hypotonic degassed water as the coupling fluid. (n=97) Receives: Procedure: Hypotonic degassed water coupling |
| Isotonic Group | Experimental | Patients in this group received extracorporeal shock wave lithotripsy (ESWL) using 0.9% NaCl (isotonic) solution as the coupling fluid. (n=99) Receives: Procedure: Isotonic (0.9% NaCl) coupling |
| Hypertonic Group | Experimental | Patients in this group received extracorporeal shock wave lithotripsy (ESWL) using 3% NaCl (hypertonic) solution as the coupling fluid. (n=98) Receives: Procedure: Hypertonic (3% NaCl) coupling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone Fragmentation Success Rate
The percentage of patients achieving successful stone fragmentation, defined as residual fragments smaller than 4 mm.
Measured: 2-4 weeks after the ESWL procedure
Post-ESWL Pain Scores
Pain intensity assessed using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain.
Measured: Immediately after the ESWL procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jul 2023
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMET MURAT BAYRAKTAR, Konya City Hospital
- Investigators
- Ahmet Murat Bayraktar, MD, Principal investigator, University of Health Sciences, Konya City Hospital, Department of Urology, Konya, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585435
- Sponsor's protocol ID
- 23/153
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the article, including demographic characteristics (age, sex), stone characteristics (size, location), pain scores (Visual Analog Scale), and stone fragmentation success rates.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Impedance Matching in ESWL: A Comparative Analysis of Hypotonic, Isotonic and Hypertonic Coupling Fluids
- ClinicalTrials.gov ID
- NCT07585435
- Acronym / sponsor ID
- 23/153
- Conditions
- Kidney Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 13 May 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.
The purpose of this study is to investigate the effect of different salt concentrations (tonicity) in the coupling fluid used during Extracorporeal Shock Wave Lithotripsy (ESWL). The study compares three types of coupling fluids: hypotonic (degassed water), isotonic (0.9% NaCl), and hypertonic (3% NaCl) solutions. Researchers aim to determine which solution provides the best stone fragmentation success while minimizing procedure-related pain and skin complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypotonic Group | Active comparator | Procedure: Hypotonic degassed water couplingPatients in this group received extracorporeal shock wave lithotripsy (ESWL) using hypotonic degassed water as the coupling fluid. (n=97) |
| Isotonic Group | Experimental | Procedure: Isotonic (0.9% NaCl) couplingPatients in this group received extracorporeal shock wave lithotripsy (ESWL) using 0.9% NaCl (isotonic) solution as the coupling fluid. (n=99) |
| Hypertonic Group | Experimental | Procedure: Hypertonic (3% NaCl) couplingPatients in this group received extracorporeal shock wave lithotripsy (ESWL) using 3% NaCl (hypertonic) solution as the coupling fluid. (n=98) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with kidney stones measuring 5-20 mm.
- Patients scheduled for ESWL treatment.
- Age 18 and older
Key exclusion criteria (4 listed)
- Pregnancy.
- Uncorrected bleeding disorders.
- Active urinary tract infection.
- Anatomical abnormalities preventing ESWL.
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 |
|---|---|---|
| Hypotonic degassed water couplingHypotonic degassed water was used as the coupling fluid during the ESWL procedure. | Procedure or surgery | Hypotonic Group |
| Isotonic (0.9% NaCl) coupling0.9% NaCl (isotonic) solution was used as the coupling fluid during the ESWL procedure. | Procedure or surgery | Isotonic Group |
| Hypertonic (3% NaCl) coupling3% NaCl (hypertonic) solution was used as the coupling fluid during the ESWL procedure. | Procedure or surgery | Hypertonic Group |
Primary outcome
Stone Fragmentation Success Rate
Time frame: 2-4 weeks after the ESWL procedure
The percentage of patients achieving successful stone fragmentation, defined as residual fragments smaller than 4 mm.
Post-ESWL Pain Scores
Time frame: Immediately after the ESWL procedure
Pain intensity assessed using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain.
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 13 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in the article, including demographic characteristics (age, sex), stone characteristics (size, location), pain scores (Visual Analog Scale), and stone fragmentation success rates.
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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.
Ahmet Murat Bayraktar, MD principal investigator
University of Health Sciences, Konya City Hospital, Department of Urology, Konya, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypotonic degassed water coupling, Isotonic (0.9% NaCl) coupling and Hypertonic (3% NaCl) coupling in people with Kidney Stones, run by Konya City Hospital at 1 site in Turkey (Türkiye).
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 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 13 May 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 Turkey (Türkiye). 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 Fragmentation Success Rate (time frame: 2-4 weeks after the ESWL procedure). The study lists 2 primary outcomes in all. 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 13 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.