Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone

NCT ID: NCT05896345

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2021-12-01

Brief Summary

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

Detailed Description

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Conditions

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Pediatric Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SWL

Shockwave Lithotripsy (SWL)

Group Type ACTIVE_COMPARATOR

SWL

Intervention Type DEVICE

Shockwave Lithotripsy (SWL) For Paediatrics Radiolucent Renal Stone

SWL and ODT

Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT)

Group Type ACTIVE_COMPARATOR

SWL and ODT

Intervention Type COMBINATION_PRODUCT

Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone

Interventions

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SWL

Shockwave Lithotripsy (SWL) For Paediatrics Radiolucent Renal Stone

Intervention Type DEVICE

SWL and ODT

Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urology and Nephrology Center

Al Mansurah, Outside U.S./Canada, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Paediatrics RLS

Identifier Type: -

Identifier Source: org_study_id

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