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Completed

NCT Number: NCT03763539

Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value

Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value

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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef Hospitals

Banī Suwayf, Outside U.S./Canada, Egypt

About this study

To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • single renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)
  • radio-opaque stone
  • high attenuation value (≥ 1000 HU) stone

Exclusion criteria

  • Abnormal renal anatomy
  • renal insufficiency
  • solitary kidney
  • coagulopathies
  • uncontrolled hypertension
  • renal artery or aortic aneurysm
  • active urinary tract infection
  • pregnancy
  • severe skeletal malformations (spinal deformity) precluding proper stone localization
  • skin to stone distance (SSD) > 11 cm
  • BMI > 30 Kgm/m2

Treatment and study plan

SWL

Procedure

Shock wave lithotripsy

Other names: ESWL

Primary outcomes

  1. stone free rate

    Time frame: 3 months following last session of SWL

    Complete clearance of stones in addition to clinically insignificant residual fragments

Secondary outcomes

  1. Complications

    Time frame: 1 year following last session of SWL

    Comparison of complications in both groups

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: SWL

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Dec 4, 2018
Registry last updated
Dec 4, 2018

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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