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Clinical trial

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

ID
Name
Paediatrics RLS
Description
To conduct a RCT comparing SWL versus combined ODT and SWL as non-invasive methods for management of paediatrics radiolucent renal stone.
Trial arms
Trial start
2018-05-01
Estimated PCD
2021-12-01
Trial end
2021-12-01
Status
Completed
Treatment
SWL
Shockwave Lithotripsy (SWL) For Paediatrics Radiolucent Renal Stone
Arms:
SWL
SWL and ODT
Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone
Arms:
SWL and ODT
Size
76
Primary endpoint
Assess the stone free rate measured by computed tomograghy as asymptomatic insignificant residual fragments less than 3 mm
3 month
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 76, 'type': 'ACTUAL'}}
Updated at
2023-06-09

1 organization

1 product

1 indication

Organization
Mansoura University
Product
SWL
Indication
Pediatric Kidney Disease