NCT05413603

Brief Summary

Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

May 19, 2022

Last Update Submit

July 6, 2023

Conditions

Stone, KidneyChild, Only

Keywords

pediatric renal stonesultrasound shock wavesfluoroscope.

Outcome Measures

Primary Outcomes (1)

  • Lithotripsy or nephrolithotripsy by Shock waves

    Incidence of success of Nephrolithotripsy by using Fluoroscopic shock waves or Ultrasonic shock waves in pediatric renal pelvic stones.

    from baseline to 3 months after the Lithotripsy date.

Secondary Outcomes (1)

  • Complications of shockwave lithotripsy

    through study completion, an average of 1 year

Study Arms (2)

fluoroscopic focus Shock wave lithotripsy

ACTIVE COMPARATOR

Shock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone

Procedure: ultrasonic focus Shock wave lithotripsyProcedure: fluoroscopic focus Shock wave lithotripsy

ultrasonic focus Shock wave lithotripsy

ACTIVE COMPARATOR

Shock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone

Procedure: ultrasonic focus Shock wave lithotripsyProcedure: fluoroscopic focus Shock wave lithotripsy

Interventions

ultrasonic focus Shock wave lithotripsyPROCEDURE

successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone

fluoroscopic focus Shock wave lithotripsyultrasonic focus Shock wave lithotripsy
fluoroscopic focus Shock wave lithotripsyPROCEDURE

successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone

fluoroscopic focus Shock wave lithotripsyultrasonic focus Shock wave lithotripsy

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm

You may not qualify if:

  • Previous percutaneous nephrolithotripsy at the same side.
  • Previous renal exploration for stones at the same side.
  • Positive urinary culture.
  • Calyceal stones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology department - faculty of medicine, South Valley university

Qina, Egypt

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mahmoud Moubarak, Resident

    Urology department - faculty of medicine, South Valley university.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2022

First Posted

June 10, 2022

Study Start

May 25, 2022

Primary Completion

May 25, 2023

Study Completion

May 30, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations

EG(1)