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

December 3, 2018 updated by: Mohammed Said ElSheemy, Cairo University
Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Outside U.S./Canada
      • Banī Suwayf, Outside U.S./Canada, Egypt
        • Beni-Suef Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultraslow shock wave lithotripsy (SWL)

SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes.

The rest of the session at 22kv (full power).
Procedure: SWL
Shock wave lithotripsy
Other Names:
  • ESWL
Active Comparator: Slow power-ramping SWL
SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW.
Procedure: SWL
Shock wave lithotripsy
Other Names:
  • ESWL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stone free rate
Time Frame: 3 months following last session of SWL
Complete clearance of stones in addition to clinically insignificant residual fragments
3 months following last session of SWL

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 1 year following last session of SWL
Comparison of complications in both groups
1 year following last session of SWL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

December 1, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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