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Completed

NCT Number: NCT02658942

Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones

to assess safety, efficacy of Flexible ureteroscopy (FURS) holmium:YAG laser lithotripsy (LL) compared to extracorporeal shockwave lithotripsy (ESWL) in management of lower calyceal stones (LC) stones.

Completed

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Key information

Conditions

Renal Stones Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, 12222, Egypt

About this study

to assess stone free rate, number of sessions and complications of flexible ureteroscopy holmium:YAG laser lithotripsy compared to extracorporeal shockwave lithotripsy in the management of lower calyceal stones less than 2 cm in size.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • unilateral
  • radiopaque stone(s)
  • < 2 cm
  • located in the lower calyx.

Exclusion criteria

  • Bleeding tendency
  • distal obstruction
  • Anomalies of the urinary tract
  • Solitary kidney

Treatment and study plan

Ureteroscopy

Procedure

In Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber.

Other names: Flexible Ureteroscopy

Shockwave lithotripsy

Procedure

In Group B patients, a Siemens Lithostar Lithotriptor

Other names: ESWL

Primary outcomes

  1. Stone free rate

    Time frame: 3 months

    no stone fragments or having fragments <3mm

Secondary outcomes

  1. Complications

    Time frame: 3 years

    Bleeding Infection Pain obstruction renal or ureteric injury UTI Fever

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones: A Prospective Randomized Study

Important dates

Study start
2010
Primary completion
2012
Study completion
2015
First posted
Jan 20, 2016
Registry last updated
Jan 20, 2016

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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