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

NCT ID: NCT03763539

Last Updated: 2018-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-05-31

Brief Summary

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

Detailed Description

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

Conditions

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Renal Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

SWL

Intervention Type PROCEDURE

Shock wave lithotripsy

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.

Group Type ACTIVE_COMPARATOR

SWL

Intervention Type PROCEDURE

Shock wave lithotripsy

Interventions

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SWL

Shock wave lithotripsy

Intervention Type PROCEDURE

Other Intervention Names

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ESWL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Said ElSheemy

Associate Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmad Aref Al-Dessoukey, Ass. Prof.

Role: STUDY_DIRECTOR

Beni-Suef University

Locations

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Beni-Suef Hospitals

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

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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5124

Identifier Type: -

Identifier Source: org_study_id

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