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Procedure

Mini-PNCL vs fURS for Kidney Stones

N/A
Waitlist Available
Led By Hazem Elmansy, MD
Research Sponsored by Thunder Bay Regional Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx
Be older than 18 years old
Must not have
Participants who lack the capacity to provide free and informed written consent
Patients with solitary kidney
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two methods for removing lower pole kidney stones in patients with stones that are 1-2 cm in size. One method uses a small surgical cut without leaving a tube, while the other uses a flexible tool inserted through the urinary tract. The goal is to see which method is more effective and has fewer complications.

Who is the study for?
This trial is for adults over 18 with single kidney stones sized 10-20 mm or multiple stones in one calyx. They must be able to follow the study's procedures and give written consent. It excludes those with larger/multiple stones, previous treatments, urinary infections, bleeding disorders, pregnancy, extreme obesity, or certain preexisting conditions.
What is being tested?
The trial compares two techniques for treating lower pole kidney stones: mini-percutaneous nephrolithotomy (Mini-PNCL) and flexible ureteroscopy (fURS). The goal is to see which method is safer and more effective when performed as a same-day procedure without hospital admission.
What are the potential side effects?
Possible side effects include pain at the surgical site, bleeding, infection risk from surgery, potential damage to surrounding tissues or organs during the procedure. There may also be complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a kidney stone or stones in one area, measuring 10-20 mm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand and sign the consent form by myself.
Select...
I have only one kidney.
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I have had shock wave therapy for the same kidney stone before.
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I have a kidney stone larger than 20 mL or multiple stones in different parts of my kidney.
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I cannot stop my blood thinners before surgery.
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I have a stone or narrowing in the tube on the same side as my bladder.
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I had kidney surgery on the same side within the last 5 years.
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I was born with abnormalities in my kidney, ureters, or bladder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Stone-free status
Secondary study objectives
Pain
To compare safety measures
To compare stone free status of single use vs reusable fURS

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Flexible ureteroscopy (fURS)Active Control1 Intervention
Retrograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding.
Group II: Mini-percutaneous nephrolithotomy (mini-PCNL)Active Control1 Intervention
PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs)4

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for kidney stones, such as the Ambulatory Tubeless Miniperc and retrograde intrarenal surgery (RIRS), work by physically removing the stones from the kidney. The Ambulatory Tubeless Miniperc involves percutaneous removal without a nephrostomy tube, which helps to reduce postoperative pain, morbidity, and hospital stay. These minimally invasive techniques are designed to break down and extract stones, providing relief from symptoms and preventing further complications. This approach is significant for patients as it aims to enhance recovery and improve overall quality of life by minimizing the invasiveness and associated risks of the procedure.

Find a Location

Who is running the clinical trial?

Thunder Bay Regional Research InstituteLead Sponsor
8 Previous Clinical Trials
543 Total Patients Enrolled
1 Trials studying Kidney Stones
174 Patients Enrolled for Kidney Stones
Thunder Bay Regional Health Research InstituteLead Sponsor
10 Previous Clinical Trials
785 Total Patients Enrolled
1 Trials studying Kidney Stones
174 Patients Enrolled for Kidney Stones
Hazem Elmansy, MDPrincipal InvestigatorThunder Bay Regional Health Sciences Centre
4 Previous Clinical Trials
482 Total Patients Enrolled
1 Trials studying Kidney Stones
174 Patients Enrolled for Kidney Stones

Media Library

Flexible ureteroscopy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04389853 — N/A
Kidney Stones Research Study Groups: Flexible ureteroscopy (fURS), Mini-percutaneous nephrolithotomy (mini-PCNL)
Kidney Stones Clinical Trial 2023: Flexible ureteroscopy Highlights & Side Effects. Trial Name: NCT04389853 — N/A
Flexible ureteroscopy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04389853 — N/A
~15 spots leftby Oct 2025
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