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
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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COMPLETED
NA
196 participants
INTERVENTIONAL
2015-09-30
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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).
SWL
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.
SWL
Shock wave lithotripsy
Interventions
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SWL
Shock wave lithotripsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* radio-opaque stone
* high attenuation value (≥ 1000 HU) stone
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mohammed Said ElSheemy
Associate Professor of Urology
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
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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5124
Identifier Type: -
Identifier Source: org_study_id
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