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OpenTrials
Completed

NCT Number: NCT07445646

Efficacy of Different Modalities on Management of Renal Hard Stones

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.

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Key information

Conditions

Urolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stone, Kidney Urinary Calculi Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elsayed Abdelhalim

Zagazig, 44749, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Lithotripsy using Flexible ureteroscope

Procedure

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

Extracorporeal shock wave lithotripsy (ESWL)

Procedure

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

holmium laser lithotripsy using Karl® Storz MIP

Procedure

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

Primary outcomes

  1. stone free rate

    Time frame: two weeks from primary procedure

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

Secondary outcomes

  1. ssess operative time

    Time frame: during the procedure

    assess operative time.in minutes

  2. Radiation time

    Time frame: during the procedure

    Time of patient exposure for radiation in minutes

  3. Post operative complication

    Time frame: Up to 48 hours

    Complication may occur post operative complication like fever, sever pain

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Comparative Outcomes of FURS, ESWL and Mini-PCNL for Non-Lower Pole Hard Renal Stones: A Prospective Randomized Study.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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