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Procedure
Mini-PNCL vs fURS for Kidney Stones
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial will compare the safety and effectiveness of two different procedures for treating kidney stones. One is a same-day, minimally invasive procedure called "tubeless mini-PCNL." The other is a less invasive procedure called "fURS."
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.Check my eligibility
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.See study design
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 belowSelect...
I have a kidney stone or stones in one area, measuring 10-20 mm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Stone-free status
Secondary outcome measures
Pain
To compare safety measures
To compare stone free status of single use vs reusable fURS
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
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Who is running the clinical trial?
Thunder Bay Regional Research InstituteLead Sponsor
8 Previous Clinical Trials
762 Total Patients Enrolled
1 Trials studying Kidney Stones
174 Patients Enrolled for Kidney Stones
Thunder Bay Regional Health Research InstituteLead Sponsor
9 Previous Clinical Trials
862 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand and sign the consent form by myself.I have a kidney stone or stones in one area, measuring 10-20 mm.I have only one kidney.I have had shock wave therapy for the same kidney stone before.You are pregnant or extremely overweight.I have a kidney stone larger than 20 mL or multiple stones in different parts of my kidney.I am over 18 years old.I do not have an active urinary tract infection, or it is being treated.I cannot stop my blood thinners before surgery.I have a stone or narrowing in the tube on the same side as my bladder.I had kidney surgery on the same side within the last 5 years.You have a tube inserted in the same side of your body as the study.I was born with abnormalities in my kidney, ureters, or bladder.
Research Study Groups:
This trial has the following groups:- Group 1: Flexible ureteroscopy (fURS)
- Group 2: Mini-percutaneous nephrolithotomy (mini-PCNL)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being studied for this research endeavor?
"Affirmative. Documents held on clinicaltrials.gov manifest that this trial, which was initially uploaded onto 10/5/2020, is actively recruiting participants. The study requires 72 volunteers to be recruited across 1 medical centre."
Answered by AI
Does this research program have any vacancies?
"Affirmative. The online record at clinicaltrials.gov displays that this investigation is actively seeking participants, having first been uploaded on October 5th 2020 and updated recently on October 18th 2022. This trial requires 72 participants to partake across 1 medical facility."
Answered by AI
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