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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03763539
Other study ID # 5124
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date May 2018

Study information

Verified date December 2018
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date May 2018
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
SWL
Shock wave lithotripsy

Locations

Country Name City State
Egypt Beni-Suef Hospitals Bani Suwayf Outside U.S./Canada

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary stone free rate Complete clearance of stones in addition to clinically insignificant residual fragments 3 months following last session of SWL
Secondary Complications Comparison of complications in both groups 1 year following last session of SWL
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