NCT07445646

Brief Summary

The study has been conducted in Urology department at Kafrelsheikh University Hospital between Feburary 2021 to December 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) while, Group B : extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) .Group C : Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

February 25, 2026

Last Update Submit

March 2, 2026

Conditions

UrolithiasisStone, Kidney

Outcome Measures

Primary Outcomes (1)

  • stone free rate

    no stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up two weeks.

    two weeks from primary procedure

Secondary Outcomes (3)

  • ssess operative time

    during the procedure

  • Radiation time

    during the procedure

  • Post operative complication

    Up to 48 hours

Study Arms (3)

Group A :Flexible ureteroscope group

ACTIVE COMPARATOR

Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue)

Procedure: Lithotripsy using Flexible ureteroscope

Group B : extracorporeal shock wave lithotripsy (ESWL) group

ACTIVE COMPARATOR

extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany)

Procedure: Extracorporeal shock wave lithotripsy (ESWL)

Group C : Mini perc group

ACTIVE COMPARATOR

Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.

Procedure: holmium laser lithotripsy using Karl® Storz MIP

Interventions

Lithotripsy using Flexible ureteroscopePROCEDURE

using Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate

Group A :Flexible ureteroscope group
Extracorporeal shock wave lithotripsy (ESWL)PROCEDURE

using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate

Group B : extracorporeal shock wave lithotripsy (ESWL) group
holmium laser lithotripsy using Karl® Storz MIPPROCEDURE

using holmium laser lithotripsy using Karl® Storz MIP set to get high stone clearance rate

Group C : Mini perc group

Eligibility Criteria

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

You may qualify if:

  • Adult patient older than 18 years.
  • single renal stone.
  • medium sized Stone up to 2.0 cm .
  • Do novo
  • Stone in plevicalyceal except lower calyceal stone
  • Hard stone

You may not qualify if:

  • multiple renal stones
  • Stone in lower calyceal stone
  • stone size \> 2 cm
  • age group \< 18
  • solitary kidney
  • Patients with BMI \> 40 kg/m2
  • bleeding disorders
  • anatomical renal abnormalities
  • Obstruction distal to the stone.
  • Musculoskeletal deformities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elsayed Abdelhalim

Zagazig, 44749, Egypt

Location

MeSH Terms

Conditions

UrolithiasisKidney Calculi

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephrolithiasisKidney DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, Operative

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
assistant lecturer of urology

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

February 1, 2021

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

EG(1)