UrolithiasisNCT07337954
3D-CT vs Ellipsoid for JJ Stent Prediction Before ESWL
A study testing Extracorporeal shock wave lithotripter in people with Urolithiasis and Shock Wave Lithotripsy, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective single-center study compares 3D-CT volumetry versus traditional ellipsoid formula to determine critical stone burden predicting JJ stent necessity before ESWL for 1-2 cm renal stones. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Urolithiasis, Shock Wave Lithotripsy, Ureteral Stents
- What is being tested?
- Extracorporeal shock wave lithotripter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Jun 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- BMI 18-30 kg/m²
- Single radio-opaque renal stone 1-2 cm
- Suitable for ESWL per clinical assessment
Who cannot join
- Multiple renal stones
- Solitary kidney
- Impaired renal function
- Congenital renal anomalies
- Ureteric obstruction
- Systemic comorbidities
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Ain Shams University
Cairo, Cairo Governorate, 1151
About this study
Official title: Estimation of Critical Stone Burden Requiring JJ Stent Before Extracorporeal Shockwave Lithotripsy Using 3D-CT
This prospective single-center study compares 3D-CT volumetry versus traditional ellipsoid formula to determine critical stone burden predicting JJ stent necessity before ESWL for 1-2 cm renal stones. Fifty-six patients with single radio-opaque renal stones will receive up to two ESWL sessions using Dornier lithotripter without initial stenting. Stone characteristics will be assessed via NCCT: linear dimensions (ellipsoid formula), 3D volume (voxel-based segmentation), Hounsfield units, and skin-to-stone distance. Patients will be stratified by ESWL outcomes to compare volume measurements between clearance success and stent-requiring groups..
Read the detailed description
This prospective single-center study at Ain Shams University evaluates 3D-CT volumetry versus traditional ellipsoid formula for predicting critical stone burden requiring preoperative JJ stent placement in patients undergoing ESWL for 1-2 cm renal stones. Eligible patients (target n=56) with single radio-opaque renal stones will receive two ESWL sessions using Dornier lithotripter without initial stenting. Stone characteristics will be assessed via non-contrast CT (NCCT): linear dimensions (ellipsoid formula: length×width×height×0.52), 3D volume (automated voxel-based segmentation), Hounsfield units, and skin-to-stone distance.
Patients will be stratified by ESWL outcomes: stone clearance without stenting versus those requiring JJ stent due to complications (infection, incomplete fragmentation, obstruction/Stein Strasse). Volume measurements will be compared between groups using appropriate statistical tests (t-test, ROC analysis). The study aims to establish a 3D-CT volume threshold for stent prediction and validate its superiority over ellipsoid formula, particularly for irregular stone morphology.
- Conditions
- Urolithiasis, Shock Wave Lithotripsy, Ureteral Stents
- Being tested
- Extracorporeal shock wave lithotripter
- Keywords
- stone volume, 3D-CT, volumetry, stent necessity, stone burden
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave lithotripterDevice
ESWL delivered at 70-80 shocks/min, max 2500 shocks/session, voltage ramped to 90 kV. Stone localization via fluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| ESWL without Initial JJ Stent | Experimental | All 56 patients received standardized ESWL treatment using third-generation Dornier lithotripter (maximum 2 sessions, 2500 shock waves/session). No preoperative JJ stent placement. Stone volume assessed via dual methods: 3D-CT volumetry (voxel-based segmentation) and ellipsoid formula (greatest dimensions on NCCT). Follow-up at 2 weeks with KUB/ultrasound; JJ stent placed for complications (incomplete fragmentation, obstruction, Stein Strasse, infection) Receives: Device: Extracorporeal shock wave lithotripter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone Volume by 3D-CT Volumetry
Comparison of stone volume measured by 3D-CT volumetry (voxel-based segmentation, cm³) versus traditional ellipsoid formula (greatest dimensions method) to determine critical stone burden predicting JJ stent necessity after ESWL. ROC analysis identified optimal cutoff (>1.88 cm³) for stent requirement
Measured: Pre-ESWL baseline
Secondary outcomes (2)
JJ Stent Necessity
Rate of JJ stent placement due to ESWL complications (incomplete fragmentation, obstruction, Stein Strasse, infection)
Measured: 2 weeks post-ESWL
ESWL Success Rate
Stone-free rate (complete clearance or asymptomatic fragments <4mm on KUB/ultrasound)
Measured: 2 weeks after maximum 2 ESWL sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All 56 patients underwent standardized ESWL protocol (Dornier lithotripter, 2 sessions max, no initial JJ stent) with dual stone volume assessment: 3D-CT volumetry (voxel-based segmentation) vs ellipsoid formula (greatest dimensions). Patients stratified post-hoc by outcomes: success without stenting (n=14) vs complications requiring stent (n=42). No randomization; single treatment arm with diagnostic comparison
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Elawady, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337954
- Sponsor's protocol ID
- FMASU MS872024
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared. Summary results are available in the publication and ClinicalTrials.gov results database.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Critical Stone Burden Requiring JJ Stent Before Extracorporeal Shockwave Lithotripsy Using 3D-CT
- ClinicalTrials.gov ID
- NCT07337954
- Acronym / sponsor ID
- FMASU MS872024
- Conditions
- Urolithiasis, Shock Wave Lithotripsy, Ureteral Stents
- Keywords
- stone volume, 3D-CT, volumetry, stent necessity, stone burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Jan 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.
This prospective single-center study compares 3D-CT volumetry versus traditional ellipsoid formula to determine critical stone burden predicting JJ stent necessity before ESWL for 1-2 cm renal stones. Fifty-six patients with single radio-opaque renal stones will receive up to two ESWL sessions using Dornier lithotripter without initial stenting. Stone characteristics will be assessed via NCCT: linear dimensions (ellipsoid formula), 3D volume (voxel-based segmentation), Hounsfield units, and skin-to-stone distance. Patients will be stratified by ESWL outcomes to compare volume measurements between clearance success and stent-requiring groups..
Detailed description
This prospective single-center study at Ain Shams University evaluates 3D-CT volumetry versus traditional ellipsoid formula for predicting critical stone burden requiring preoperative JJ stent placement in patients undergoing ESWL for 1-2 cm renal stones. Eligible patients (target n=56) with single radio-opaque renal stones will receive two ESWL sessions using Dornier lithotripter without initial stenting. Stone characteristics will be assessed via non-contrast CT (NCCT): linear dimensions (ellipsoid formula: length×width×height×0.52), 3D volume (automated voxel-based segmentation), Hounsfield units, and skin-to-stone distance.
Patients will be stratified by ESWL outcomes: stone clearance without stenting versus those requiring JJ stent due to complications (infection, incomplete fragmentation, obstruction/Stein Strasse). Volume measurements will be compared between groups using appropriate statistical tests (t-test, ROC analysis). The study aims to establish a 3D-CT volume threshold for stent prediction and validate its superiority over ellipsoid formula, particularly for irregular stone morphology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All 56 patients underwent standardized ESWL protocol (Dornier lithotripter, 2 sessions max, no initial JJ stent) with dual stone volume assessment: 3D-CT volumetry (voxel-based segmentation) vs ellipsoid formula (greatest dimensions). Patients stratified post-hoc by outcomes: success without stenting (n=14) vs complications requiring stent (n=42). No randomization; single treatment arm with diagnostic comparison
| Arm | Type | Receives |
|---|---|---|
| ESWL without Initial JJ Stent | Experimental | Device: Extracorporeal shock wave lithotripterAll 56 patients received standardized ESWL treatment using third-generation Dornier lithotripter (maximum 2 sessions, 2500 shock waves/session). No preoperative JJ stent placement. Stone volume assessed via dual methods: 3D-CT volumetry (voxel-based segmentation) and ellipsoid formula (greatest dimensions on NCCT). Follow-up at 2 weeks with KUB/ultrasound; JJ stent placed for complications (incomplete fragmentation, obstruction, Stein Strasse, infection) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- BMI 18-30 kg/m²
- Single radio-opaque renal stone 1-2 cm
- Suitable for ESWL per clinical assessment
Key exclusion criteria (7 listed)
- Multiple renal stones
- Solitary kidney
- Impaired renal function
- Congenital renal anomalies
- Ureteric obstruction
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 lithotripterESWL delivered at 70-80 shocks/min, max 2500 shocks/session, voltage ramped to 90 kV. Stone localization via fluoroscopy. | Device | ESWL without Initial JJ Stent |
Primary outcome
Stone Volume by 3D-CT Volumetry
Time frame: Pre-ESWL baseline
Comparison of stone volume measured by 3D-CT volumetry (voxel-based segmentation, cm³) versus traditional ellipsoid formula (greatest dimensions method) to determine critical stone burden predicting JJ stent necessity after ESWL. ROC analysis identified optimal cutoff (>1.88 cm³) for stent requirement
2 secondary outcomes
JJ Stent Necessity
Time frame: 2 weeks post-ESWL
ESWL Success Rate
Time frame: 2 weeks after maximum 2 ESWL sessions
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 Jan 2026.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared. Summary results are available in the publication and ClinicalTrials.gov results database.
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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 Extracorporeal shock wave lithotripter in people with Urolithiasis and Shock Wave Lithotripsy, run by Ain Shams 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 4 inclusion and 7 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 Jan 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 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 Volume by 3D-CT Volumetry (time frame: Pre-ESWL baseline). 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 Jan 2026.