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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
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Kidney Disease

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 31, 2023
Last Updated
May 31, 2023
Sponsor
Mansoura University
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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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