NCT07072598 · Northwestern University
Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS
What this study is about
The objective of the study is to compare the stone free rates with ureteroscopy utilizing the ClearPETRA suction ureteral access sheath, and mini-PCNL; both procedures and ClearPETRA sheaths are the usual treatment and are used regularly for stone treatment. Our primary objective is to assess the complete stone free rate with both procedures.
View original scientific description
The objective of the study is to compare the stone free rates with ureteroscopy utilizing the ClearPETRA suction ureteral access sheath, and mini-PCNL; both procedures and ClearPETRA sheaths are standard of care and are used regularly for stone treatment. Our primary objective is to assess the complete stone free rate with both procedures.
Interventions
DEVICE
ClearPETRA suction access sheath
Ureteroscopy utilizing the ClearPETRA suction access sheath.
DEVICE
ClearPETRA suction access sheath
Mini-PCNL utilizing the ClearPETRA suction access sheath
Primary outcome measures
Stone free rate
Time frame: 4 weeks post-procedure
Stone free rate (no residual stone) on post-procedure CT
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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\
- Non-recruitment of non-english speakers is due to the study being a small pilot study that is used to assess the stone free rate for patients treated with a ureteroscopy or mini-PCNL using ClearPETRA suction access sheaths in a small portion of our patient population seeking treatment for stones. The team also does not possess the bandwidth or personnel to consent patients who are non-English speaking.
Where
- Chicago, Illinois
Collaborators
KARL STORZ Endoscopy-America, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations