NCT07753733

Brief Summary

This randomized, parallel-group, non-inferiority trial will compare flexible nephroscopy-assisted single-tract percutaneous nephrolithotomy with conventional multi-tract percutaneous nephrolithotomy in patients with complex unilateral renal stones. The primary outcome is stone-free rate at 3 months, and secondary outcomes include operative time, fluoroscopy time, hemoglobin drop, transfusion rate, hospital stay, complications, need for auxiliary procedures, and cost-effectiveness.

Trial Health

65
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Trial Health Score

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

Enrollment
470

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

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 Progress1%
Jul 2026Aug 2028

First Submitted

Initial submission to the registry

July 29, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 30, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2028

Last Updated

August 7, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

July 29, 2026

Last Update Submit

August 6, 2026

Conditions

Percutaneous Nephrolithotomy

Keywords

Renal stonesFlexible NephroscopyMulti-tract

Outcome Measures

Primary Outcomes (1)

  • Stone-free rate at 3 months.

    Proportion of patients with no residual stone fragments greater than 4 mm on non-contrast CT.

    3 months after surgery.

Secondary Outcomes (7)

  • Operative time

    Intraoperative

  • Fluoroscopy time

    Intraoperative

  • Number of tracts

    Intraoperative

  • Hemoglobin drop

    From baseline to postoperative day 1.

  • Transfusion rate

    Perioperative/Periprocedural

  • +2 more secondary outcomes

Study Arms (2)

Flexible Nephroscopy-Assisted Single-Tract PCNL

EXPERIMENTAL

Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.

Procedure: Flexible Nephroscopy-Assisted Single-Tract PCNL

Conventional Multi-Tract PCNL

EXPERIMENTAL

Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.

Procedure: Conventional Multi-Tract PCNL

Interventions

Flexible Nephroscopy-Assisted Single-Tract PCNLPROCEDURE

Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.

Flexible Nephroscopy-Assisted Single-Tract PCNL
Conventional Multi-Tract PCNLPROCEDURE

Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.

Conventional Multi-Tract PCNL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years.
  • Unilateral complex renal stones defined by one or more of the following: Guy's Stone Score III-IV, S.T.O.N.E. score ≥9, staghorn or partial staghorn calculus, or stones involving at least 3 calyces on NCCT.
  • Preoperative expectation of multiple accesses by the surgeon.
  • Written informed consent.

You may not qualify if:

  • Solitary kidney.
  • Uncorrected coagulopathy.
  • Active urinary tract infection.
  • ASA grade IV or higher.
  • Pregnancy.
  • Previous ipsilateral PCNL or open renal surgery.
  • Stones less than 2 cm or simple calyceal stones.
  • Refusal or inability to comply with follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Central Study Contacts

Abul-fotouh Ahmed

CONTACT

00201001066756abulfotouhahmed7070@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Urology

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 7, 2026

Study Start

July 30, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

August 30, 2028

Last Updated

August 7, 2026

Record last verified: 2026-07