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Clinical Trials/NCT05896345
NCT05896345
Completed
Not Applicable

Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone. A Randomised Controlled Trial

Mansoura University1 site in 1 country76 target enrollmentStarted: May 1, 2018Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
76
Locations
1
Primary Endpoint
Assess the stone free rate measured by computed tomograghy as asymptomatic insignificant residual fragments less than 3 mm

Overview

Brief Summary

To conduct a RCT comparing SWL versus combined ODT and SWL as non-invasive methods for management of paediatrics radiolucent renal stone.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 1-2.5 cm renal stone
  • Normal Serum creatinine
  • Radiolucent stone with Hounsfield units less than 400

Exclusion Criteria

  • Bleeding diatheses.
  • Patients with a pacemaker.
  • uncontrolled UTIs.
  • Severe skeletal malformations.
  • Arterial aneurysm in the vicinity of the stone.
  • Anatomical obstruction distal to the stone.

Outcomes

Primary Outcomes

Assess the stone free rate measured by computed tomograghy as asymptomatic insignificant residual fragments less than 3 mm

Time Frame: 3 month

percentage of patient who are stone free

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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