Actively Recruiting
Comparing Efficiency and Stone-Free Rates After Mini-Percutaneous Nephrolithotomy and Flexible Ureteroscopy With Suction Access Sheaths
Led by Northwestern University · Updated on 2026-04-30
80
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
K
KARL STORZ Endoscopy-America, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two methods for treating kidney stones: ureteroscopy using the ClearPETRA suction ureteral access sheath and mini-percutaneous nephrolithotomy (mini-PCNL) with suction access sheaths. This study aims to assess and compare the rates of complete stone removal with both procedures, which are commonly used for stones up to 3 cm in size. The ClearPETRA sheath is designed to improve stone clearance and reduce complications compared to traditional access methods. Participants are randomly assigned to receive either ureteroscopy or mini-PCNL using ClearPETRA suction access sheaths. The ureteroscopy procedure involves inserting a flexible scope and using a high-power Holmium laser to break up stones, with stone fragments removed through the suction sheath and a ureteral stent placed afterward. The mini-PCNL procedure begins with cystoscopy and percutaneous renal access under fluoroscopy, followed by tract dilation and stone removal using lithotripsy, suction, or basket extraction, also concluding with a ureteral stent placement. During the study, participants will undergo assessments including a CT scan to confirm stone size before treatment and evaluation of stone-free status four weeks after the procedure. Researchers will monitor surgery time, complications, hospital stays, need for additional procedures, and costs related to the procedure and any follow-up care. Follow-up will last up to 90 days after surgery to track unplanned hospital visits and other outcomes, ensuring comprehensive evaluation of both treatment methods.
CONDITIONS
Brief Title
Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Have a CT scan showing renal stones 1-3cm in length
- Patients who will be able to read, understand, and complete patient questionnaires
You will not qualify if you...
- Pregnant individuals
- Those with anomalous renal anatomy
- Patients with a urinary diversion (ex: Ileal conduit, reservoir, bladder substitute, etc.)
- Any condition rendering patient medically unfit to undergo either procedure (Bleeding diasthesis)
- Patients who lack decisional capacity
- Patients who are non-english speakers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day (1 day)
Participants undergo either mini-percutaneous nephrolithotomy (mini-PCNL) or flexible ureteroscopy using the ClearPETRA suction access sheath to treat kidney stones.
1 visit (in-person)
Duration - Up to 90 days postoperatively
Participants are monitored for complications and stone-free status after the procedure.
Follow-up visits during the 90 days after surgery
Trial Site Locations
Total: 1 location
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
A
Alyssa McDonald, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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