NCT07193940

Brief Summary

To compare the efficacy and safety of flexible ureterorenoscopy (fURS) versus extracorporeal shock wave lithotripsy (ESWL) in managing lower calyceal renal stones ≤15 mm and \<1000 HU.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
30mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Oct 2025Oct 2028

First Submitted

Initial submission to the registry

September 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

September 18, 2025

Last Update Submit

September 28, 2025

Conditions

Kidney Stones

Outcome Measures

Primary Outcomes (1)

  • Stone-free rate at 1 months on low-dose NCCT (no fragment >2 mm; report CIRF separately)

    Stone-free rate at 1 months on low-dose NCCT (no fragment \>2 mm; report CIRF separately)

    baseline

Study Arms (2)

Flexible Ureteroscopy

EXPERIMENTAL

Interventional procedure: Flexible Ureteroscopy

Procedure: Flexible Ureteroscopy

Extracorporeal Shock Wave Lithotripsy

EXPERIMENTAL

Extracorporeal Shock Wave Lithotripsy (ESWL)

Procedure: extracorporeal shock wave lithotripsy (ESWL)

Interventions

Flexible UreteroscopyPROCEDURE

Flexible Ureterorenoscopy

Flexible Ureteroscopy
extracorporeal shock wave lithotripsy (ESWL)PROCEDURE

extracorporeal shock wave lithotripsy (ESWL)

Extracorporeal Shock Wave Lithotripsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥18 y)
  • Lower-calyx stone
  • Less than or equal15 mm
  • Mean Hounsfield (HU) \<1000

You may not qualify if:

  • Pregnancy
  • Uncorrected coagulopathy
  • Active UTI/obstruction
  • Anatomical barriers to Flexible Ureteroscopy or extracorporeal shock wave lithotripsy coupling (e.g., prohibitive SSD/BMI).
  • Cardiac devices contraindicating ESWL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, Egypt

Location

Related Publications (6)

  • Ng CF. The effect of stone size, location, and number on the outcome of extracorporeal shock wave lithotripsy. Int Braz J Urol. 2008;34(6):759-66. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684300/

    RESULT

  • Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.

    PMID: 27238616RESULT

  • Sampaio FJ, Aragao AH. Inferior pole collecting system anatomy: its probable role in extracorporeal shock wave lithotripsy. J Urol. 1992 Feb;147(2):322-4. doi: 10.1016/s0022-5347(17)37226-9.

    PMID: 1732584RESULT

  • Akman T, Binbay M, Ozgor F, Ugurlu M, Tekinarslan E, Kezer C, Aslan R, Muslumanoglu AY. Comparison of percutaneous nephrolithotomy and retrograde flexible nephrolithotripsy for the management of 2-4 cm stones: a matched-pair analysis. BJU Int. 2012 May;109(9):1384-9. doi: 10.1111/j.1464-410X.2011.10691.x. Epub 2011 Oct 28.

    PMID: 22093679RESULT

  • Somani BK, Giusti G, Sun Y, Osther PJ, Frank M, De Sio M, Turna B, de la Rosette J. Complications associated with ureterorenoscopy (URS) related to treatment of urolithiasis: the Clinical Research Office of Endourological Society URS Global study. World J Urol. 2017 Apr;35(4):675-681. doi: 10.1007/s00345-016-1909-0. Epub 2016 Aug 4.

    PMID: 27492012RESULT

  • Fankhauser CD, Weber D, Muntener M, Poyet C, Sulser T, Hermanns T. Effectiveness of Flexible Ureterorenoscopy Versus Extracorporeal Shock Wave Lithotripsy for Renal Calculi of 5-15 mm: Results of a Randomized Controlled Trial. Eur Urol Open Sci. 2021 Feb 2;25:5-10. doi: 10.1016/j.euros.2021.01.001. eCollection 2021 Mar.

    PMID: 34337498RESULT

Related Links

MeSH Terms

Conditions

Kidney Calculi

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Ahmed A Ahmed Atef Mohamed Abdellatif, MD

CONTACT

+0201069339244aboatef775599@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 18, 2025

First Posted

September 26, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations

EG(1)