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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03795532
Other study ID # 16224
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 11, 2019
Est. completion date June 2019

Study information

Verified date January 2019
Source Cairo University
Contact Mohammed S ElSheemy, Ass. Prof.
Phone 01006117755
Email mohammedshemy@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL for renal stones


Recruitment information / eligibility

Status Recruiting
Enrollment 124
Est. completion date June 2019
Est. primary completion date May 2019
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 (2)

Lead Sponsor Collaborator
Cairo University Beni-Suef 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 rate Comparison of rate of complications in both groups 3 months following last session of SWL
See also
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