An interventional study of Extracorporeal shock wave lithotripter in Urolithiasis, Shock Wave Lithotripsy and Ureteral Stents, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Ain Shams University · Not applicable, Interventional, and Diagnostic
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..
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.
278 studies on the registry are indexed under Urolithiasis; 70 are open to participants now.
This study's enrollment of 56 is below the median of 100 across 197 interventional studies indexed under Urolithiasis.
Browse Urolithiasis studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
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Exclusion Criteria:
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)
Device: Extracorporeal shock wave lithotripter
ESWL delivered at 70-80 shocks/min, max 2500 shocks/session, voltage ramped to 90 kV. Stone localization via fluoroscopy.
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
Time frame: Pre-ESWL baseline
JJ Stent Necessity
Rate of JJ stent placement due to ESWL complications (incomplete fragmentation, obstruction, Stein Strasse, infection)
Time frame: 2 weeks post-ESWL
ESWL Success Rate
Stone-free rate (complete clearance or asymptomatic fragments \<4mm on KUB/ultrasound)
Time frame: 2 weeks after maximum 2 ESWL sessions
Plan to share: 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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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Ain Shams University