NCT06892626

Brief Summary

Flexible Ureteroscopy versus Percutaneous Nephrolithotomy as Primary Treatment in Renal Stones 2-3 Cm

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

March 10, 2025

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • stone free rate percentage defined as number of patients who have no stone residual

    assessed by Plain urinary tract and ultrasound for confirmation of the presence of residual stone fragments.

    18 months

Study Arms (2)

RIRS

EXPERIMENTAL

RIRS performed in lithotomy position for which guide wire pass to the kidney, then passing ureteral dilators up to 14F and ureteral access sheath. Dusting stones by RIRS and holmium laser Fiber 200 mm, at the end of operation DJ was fixed.

Procedure: RIRS

PNL

EXPERIMENTAL

PNL performed in prone position, after passing guide wire and ureteric catheter in lithotomy position. Puncture to the kidney, passing 2 wires, then using renal dilators and access sheath to enter kidney by nephroscopy, fragment stones by pneumatic and remove stones, then place nelaton 28F at end of operation.

Procedure: PNL

Interventions

RIRSPROCEDURE

RIRS performed in lithotomy position for which guide wire pass to the kidney, then passing ureteral dilators up to 14F and ureteral access sheath. Dusting stones by RIRS and holmium laser Fiber 200 mm, at the end of operation DJ was fixed.

RIRS
PNLPROCEDURE

PNL performed in prone position, after passing guide wire and ureteric catheter in lithotomy position. Puncture to the kidney, passing 2 wires, then using renal dilators and access sheath to enter kidney by nephroscopy, fragment stones by pneumatic and remove stones, then place nelaton 28F at end of operation

PNL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.

You may not qualify if:

  • stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hesham Torad

Cairo, Cairo Governorate, 38516, Egypt

Location

MeSH Terms

Conditions

Kidney CalculiUreterolithiasisUrolithiasis

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUreteral Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 25, 2025

Study Start

January 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations