UrolithiasisNCT06144372
Extracorporeal Shockwave Lithotripsy, Electroconductive and Electrohydraulic Types
A study testing Electroconductive and Electrohydraulic types in people with Urolithiasis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the efficacy and safety of electroconductive (EC) and electrohydraulic (EH) extracorporeal shock wave lithotripsy (ESWL) for the treatment of ureter and kidney stones, this study conducted a randomized controlled trial. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Electroconductive and Electrohydraulic types
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Mar 2022to 16 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The analysis included cases of stones in the upper kidney and ureter, with diameters ranging from 5 mm to 15 mm.
Who cannot join
- Patients with musculoskeletal deformities, ongoing urinary tract infections requiring prioritized infection treatment, blood clotting disorders, and ureteral obstruction that made stone expulsion difficult were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy and Safety of Extracorporeal Shockwave Lithotripsy: A Randomized, Controlled Trial Study of Electroconductive and Electrohydraulic Types
To evaluate the efficacy and safety of electroconductive (EC) and electrohydraulic (EH) extracorporeal shock wave lithotripsy (ESWL) for the treatment of ureter and kidney stones, this study conducted a randomized controlled trial.
- Conditions
- Urolithiasis
- Being tested
- Electroconductive and Electrohydraulic types
- Keywords
- Extracorporeal shockwave lithotripsy, Urolithiasis, Radiation Exposure
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconductive and Electrohydraulic typesDevice
The patients were randomly assigned to two types of lithotripter.
| Study group | Role | What they receive |
|---|---|---|
| Electroconductive Type | Other | Sonolith i-move® shockwave lithotripter (EDAP, Lyon, France) Receives: Device: Electroconductive and Electrohydraulic types |
| Electrohydraulic Type | Other | Rifle lithotripter (HNT Medical, Seoul, Korea) Receives: Device: Electroconductive and Electrohydraulic types |
What is being measured
The primary outcome is the main question the study is designed to answer.
age
patient's records
Measured: 2 weeks
Gender
patient's records
Measured: 2 weeks
height
meters
Measured: 2 weeks
weight
kilograms
Measured: 2 weeks
smoking
patient's records
Measured: 2 weeks
drinking
patient's records
Measured: 2 weeks
Diabetes mellitus
patient's records
Measured: 2 weeks
Hypertension
patient's records
Measured: 2 weeks
Preoperative Double J stent
patient's records
Measured: 2 weeks
creatinine
patient's records
Measured: 2 weeks
Glomerular Filtration Rate
patient's records
Measured: 2 weeks
hemoglobin
patient's records
Measured: 2 weeks
Hydronephrosis grade
- Grade 0 : Normal examination with no dilation of the renal pelvis
- Grade 1 : Mild dilation of the renal pelvis only
- Grade II : Moderate dilation of the renal pelvis including a few calyces
- Grade III : Dilation of the renal pelvis with visualization of all the calyces, which are uniformly dilated, and normal renal parenchyma
- Grade IV : Similar apperance of the renal pelvis and calyces as Grade III, plus thinning of the renal parenchyma
Measured: 2 weeks
Analgesic
patient's records
Measured: 2 weeks
stone size
patient's records
Measured: 2 weeks
Stone laterality
patient's records
Measured: 2 weeks
Stone location
patient's records
Measured: 2 weeks
Stone volume
patient's records
Measured: 2 weeks
Stone shape
patient's records
Measured: 2 weeks
Stone to skin distance
patient's records
Measured: 2 weeks
Hounsfield unit
patient's records
Measured: 2 weeks
Urine color
patient's records
Measured: 2 weeks
Urine Turbidity
patient's records
Measured: 2 weeks
Urine Specific Gravity
patient's records
Measured: 2 weeks
Urine pH
patient's records
Measured: 2 weeks
Intensity
ESWL
Measured: 2 weeks
Used power
ESWL
Measured: 2 weeks
Shock
ESWL
Measured: 2 weeks
Speed
ESWL
Measured: 2 weeks
Visual analog scale for pain
0: Represents "No sensation" or "Not at all." 1-3: Indicates a very mild sensation or a low level of the experience, signifying almost no problem.
4-6: Represents a moderate level, suggesting a moderate presence of the experience or issue.
7-9: Reflects a high or severe level, signifying a significant presence or seriousness of the problem.
10: Represents "Maximal sensation" or "Extremely intense" and indicates an extreme presence or severity of the experience or issue.
Measured: 2 weeks
Satisfaction score
- Not satisfied at all.
- Very low satisfaction.
- Moderate satisfaction.
- High satisfaction.
- Very high or maximum satisfaction.
Measured: 2 weeks
Stone-free rates (%)
ESWL
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start31 Mar 2022
- Primary completion16 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Yong Cho, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144372
- Sponsor's protocol ID
- ESWL_ECEH
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used during the current study are available from the corresponding author on request.
Publications
Motolova M, Kral M. Effect of targeting and generator type on efficacy of extracorporeal shock wave lithotripsy. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 Dec;166(4):434-440. doi: 10.5507/bp.2022.029. Epub 2022 Jun 27.
PubMed 35801399
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Extracorporeal Shockwave Lithotripsy: A Randomized, Controlled Trial Study of Electroconductive and Electrohydraulic Types
- ClinicalTrials.gov ID
- NCT06144372
- Acronym / sponsor ID
- ESWL_ECEH
- Conditions
- Urolithiasis
- Keywords
- Extracorporeal shockwave lithotripsy, Urolithiasis, Radiation Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 22 Nov 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.
To evaluate the efficacy and safety of electroconductive (EC) and electrohydraulic (EH) extracorporeal shock wave lithotripsy (ESWL) for the treatment of ureter and kidney stones, this study conducted a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroconductive Type | Other | Device: Electroconductive and Electrohydraulic typesSonolith i-move® shockwave lithotripter (EDAP, Lyon, France) |
| Electrohydraulic Type | Other | Device: Electroconductive and Electrohydraulic typesRifle lithotripter (HNT Medical, Seoul, Korea) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The analysis included cases of stones in the upper kidney and ureter, with diameters ranging from 5 mm to 15 mm.
Key exclusion criteria (1 listed)
- Patients with musculoskeletal deformities, ongoing urinary tract infections requiring prioritized infection treatment, blood clotting disorders, and ureteral obstruction that made stone expulsion difficult were excluded from the study.
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 |
|---|---|---|
| Electroconductive and Electrohydraulic typesThe patients were randomly assigned to two types of lithotripter. | Device | Electroconductive Type, Electrohydraulic Type |
Primary outcome
age
Time frame: 2 weeks
patient's records
Gender
Time frame: 2 weeks
patient's records
height
Time frame: 2 weeks
meters
weight
Time frame: 2 weeks
kilograms
smoking
Time frame: 2 weeks
patient's records
drinking
Time frame: 2 weeks
patient's records
Diabetes mellitus
Time frame: 2 weeks
patient's records
Hypertension
Time frame: 2 weeks
patient's records
Preoperative Double J stent
Time frame: 2 weeks
patient's records
creatinine
Time frame: 2 weeks
patient's records
Glomerular Filtration Rate
Time frame: 2 weeks
patient's records
hemoglobin
Time frame: 2 weeks
patient's records
Hydronephrosis grade
Time frame: 2 weeks
* Grade 0 : Normal examination with no dilation of the renal pelvis * Grade 1 : Mild dilation of the renal pelvis only * Grade II : Moderate dilation of the renal pelvis including a few calyces * Grade III : Dilation of the renal pelvis with visualization of all the calyces, which are uniformly dilated, and normal renal parenchyma * Grade IV : Similar apperance of the renal pelvis and calyces as Grade III, plus thinning of the renal parenchyma
Analgesic
Time frame: 2 weeks
patient's records
stone size
Time frame: 2 weeks
patient's records
Stone laterality
Time frame: 2 weeks
patient's records
Stone location
Time frame: 2 weeks
patient's records
Stone volume
Time frame: 2 weeks
patient's records
Stone shape
Time frame: 2 weeks
patient's records
Stone to skin distance
Time frame: 2 weeks
patient's records
Hounsfield unit
Time frame: 2 weeks
patient's records
Urine color
Time frame: 2 weeks
patient's records
Urine Turbidity
Time frame: 2 weeks
patient's records
Urine Specific Gravity
Time frame: 2 weeks
patient's records
Urine pH
Time frame: 2 weeks
patient's records
Intensity
Time frame: 2 weeks
ESWL
Used power
Time frame: 2 weeks
ESWL
Shock
Time frame: 2 weeks
ESWL
Speed
Time frame: 2 weeks
ESWL
Visual analog scale for pain
Time frame: 2 weeks
0: Represents "No sensation" or "Not at all." 1-3: Indicates a very mild sensation or a low level of the experience, signifying almost no problem. 4-6: Represents a moderate level, suggesting a moderate presence of the experience or issue. 7-9: Reflects a high or severe level, signifying a significant presence or seriousness of the problem. 10: Represents "Maximal sensation" or "Extremely intense" and indicates an extreme presence or severity of the experience or issue.
Satisfaction score
Time frame: 2 weeks
1. Not satisfied at all. 2. Very low satisfaction. 3. Moderate satisfaction. 4. High satisfaction. 5. Very high or maximum satisfaction.
Stone-free rates (%)
Time frame: 2 weeks
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 22 Nov 2023.
- Background: PubMed 35801399Motolova M, Kral M. Effect of targeting and generator type on efficacy of extracorporeal shock wave lithotripsy. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 Dec;166(4):434-440. doi: 10.5507/bp.2022.029. Epub 2022 Jun 27.
- Individual participant dataSharing planned: No. The datasets used during the current study are available from the corresponding author on request.
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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.
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 Electroconductive and Electrohydraulic types in people with Urolithiasis, run by Seoul National University Hospital at 1 site in South Korea.
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 22 Nov 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 South Korea. 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?
age (time frame: 2 weeks). The study lists 32 primary outcomes in all. 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 NCT06144372, which also lists 1 linked publication.
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 22 Nov 2023.