Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone
1 other identifier
interventional
76
1 country
1
Brief Summary
To conduct a RCT comparing SWL versus combined ODT and SWL as non-invasive methods for management of paediatrics radiolucent renal stone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 31, 2023
CompletedFirst Posted
Study publicly available on registry
June 9, 2023
CompletedJune 9, 2023
May 1, 2023
3.6 years
May 31, 2023
May 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Assess the stone free rate measured by computed tomograghy as asymptomatic insignificant residual fragments less than 3 mm
percentage of patient who are stone free
3 month
Study Arms (2)
SWL
ACTIVE COMPARATORShockwave Lithotripsy (SWL)
SWL and ODT
ACTIVE COMPARATORShockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT)
Interventions
Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone
Eligibility Criteria
You may qualify if:
- cm renal stone
- Normal Serum creatinine
- Radiolucent stone with Hounsfield units less than 400
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology and Nephrology Center
Al Mansurah, Outside U.S./Canada, 35516, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2023
First Posted
June 9, 2023
Study Start
May 1, 2018
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
June 9, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share