Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone
Primary Purpose
Pediatric Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
SWL
SWL and ODT
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Kidney Disease
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.
Sites / Locations
- Urology and Nephrology Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SWL
SWL and ODT
Arm Description
Shockwave Lithotripsy (SWL)
Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05896345
Brief Title
Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone
Official Title
Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone. A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To conduct a RCT comparing SWL versus combined ODT and SWL as non-invasive methods for management of paediatrics radiolucent renal stone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SWL
Arm Type
Active Comparator
Arm Description
Shockwave Lithotripsy (SWL)
Arm Title
SWL and ODT
Arm Type
Active Comparator
Arm Description
Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT)
Intervention Type
Device
Intervention Name(s)
SWL
Intervention Description
Shockwave Lithotripsy (SWL) For Paediatrics Radiolucent Renal Stone
Intervention Type
Combination Product
Intervention Name(s)
SWL and ODT
Intervention Description
Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone
Primary Outcome Measure Information:
Title
Assess the stone free rate measured by computed tomograghy as asymptomatic insignificant residual fragments less than 3 mm
Description
percentage of patient who are stone free
Time Frame
3 month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
State/Province
Outside U.S./Canada
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone
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