NCT07349992

Brief Summary

This prospective cohort study aims to compare the safety and efficacy of retrograde intrarenal surgery combined with a high-power Holmium:YAG laser and flexible navigable suction access sheath versus mini-percutaneous nephrolithotomy in patients with 2-3 cm renal stones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

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

June 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 8, 2026

Last Update Submit

January 16, 2026

Conditions

Kidney StonesNephrolithiasis

Outcome Measures

Primary Outcomes (1)

  • Stone-Free Rate

    1 month

Secondary Outcomes (3)

  • Hemoglobin change

    postoperative first day

  • Fluoroscopy time

    Perioperative

  • Complications

    up to 4 weeks

Study Arms (2)

Retrograde Intrarenal Surgery (RIRS) Group

EXPERIMENTAL

Intervention: Procedure-Retrograde Intrarenal Surgery

Procedure: Retrograde Intrarenal Surgery

Mini-Percutaneous Nephrolithotomy (MiniPCNL) Group

EXPERIMENTAL

Intervention: Procedure- Mini Percutaneous Nephrolithotomy

Procedure: Mini Percutaneous Nephrolithotomy

Interventions

Mini Percutaneous NephrolithotomyPROCEDURE

We performed mini-percutaneous nephrolithotomy in patients with 2-3 cm renal stones.

Mini-Percutaneous Nephrolithotomy (MiniPCNL) Group
Retrograde Intrarenal SurgeryPROCEDURE

We performed retrograde intrarenal surgery combined with a high-power Holmium:YAG laser and flexible navigable suction access sheath in patients with 2-3 cm renal stones.

Retrograde Intrarenal Surgery (RIRS) Group

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • Kidney stones measuring 2-3 cm
  • Suitable for Retrograde Intrarenal Surgery (RIRS) or Mini-Percutaneous Nephrolithotomy (MiniPCNL)
  • Provided written informed consent

You may not qualify if:

  • Pregnancy
  • Renal transplantation
  • Congenital renal anomalies
  • Uncorrectable coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University Medical Faculty

Konya, Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney CalculiNephrolithiasis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 20, 2026

Study Start

June 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

TU(1)