- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07349992
Retrograde Intrarenal Surgery (RIRS) With High-Power Laser and Flexible, Navigable Suction Access Sheath (FANS) vs Mini-Percutaneous Nephrolithotomy (miniPCNL) for 2-3 cm Renal Stones
January 16, 2026 updated by: Muzaffer Tansel Kilinc, Necmettin Erbakan University
Flexible Ureterorenoscopy With High-Power Holmium: YAG Laser and Flexible, Navigable Suction Access Sheath vs Mini-Percutaneous Nephrolithotomy in 2-3 cm Kidney Stones Treatment: A Prospective Cohort Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Konya
-
Konya, Konya, Turkey (Türkiye)
- Necmettin Erbakan University Medical Faculty
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥18 years
- Kidney stones measuring 2-3 cm
- Suitable for Retrograde Intrarenal Surgery (RIRS) or Mini-Percutaneous Nephrolithotomy (MiniPCNL)
- Provided written informed consent
Exclusion Criteria:
- Pregnancy
- Renal transplantation
- Congenital renal anomalies
- Uncorrectable coagulopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Retrograde Intrarenal Surgery (RIRS) Group
Intervention: Procedure-Retrograde Intrarenal Surgery
|
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.
|
|
Experimental: Mini-Percutaneous Nephrolithotomy (MiniPCNL) Group
Intervention: Procedure- Mini Percutaneous Nephrolithotomy
|
We performed mini-percutaneous nephrolithotomy in patients with 2-3 cm renal stones.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Stone-Free Rate
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hemoglobin change
Time Frame: postoperative first day
|
postoperative first day
|
|
Fluoroscopy time
Time Frame: Perioperative
|
Perioperative
|
|
Complications
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
June 1, 2024
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
January 8, 2026
First Submitted That Met QC Criteria
January 16, 2026
First Posted (Actual)
January 20, 2026
Study Record Updates
Last Update Posted (Actual)
January 20, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urolithiasis
- Urinary Calculi
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
- Nephrolithiasis
Other Study ID Numbers
- RIRS-MiniPCNL-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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