ClearPetra for Kidney Stones
(VA-UAS vs trad Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method for treating kidney stones using a vacuum-assisted device called the ClearPetra™ Vacuum-assisted Ureteral Access Sheath. The researchers aim to determine if this device more effectively removes stones and reduces infections compared to traditional methods. The trial seeks participants with kidney stones between 1 to 2.5 cm who plan to undergo a procedure called flexible ureteroscopy. Participants will either receive the new vacuum device or undergo the standard approach without it. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance kidney stone treatment options.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the ClearPetra device is safe for use in ureteroscopy?
Research shows that the ClearPetra vacuum-assisted ureteral access sheath is generally well-tolerated. Studies on similar devices indicate they help lower pressure inside the kidney, which is important for protecting it during procedures. This suggests that the ClearPetra device is likely safe for use in people.
Specific information on side effects related to the ClearPetra device is limited, but it is designed to ease kidney stone removal and reduce complications like infections. This suggests it could be a safer option compared to traditional methods. However, like any medical device, some risks may still exist.
The ClearPetra device is new in the U.S., and while complete safety information may still be forthcoming, its approval for use means it has met certain safety standards. Discuss any concerns with a doctor before joining a trial.
Why are researchers excited about this trial?
Researchers are excited about the new ClearPetra™ vacuum-assisted ureteral access sheath because it offers a unique approach to removing kidney stones. Unlike traditional methods that rely on standard ureteral access sheaths or none at all, this innovative technique uses a vacuum-assisted mechanism to potentially improve the efficiency and effectiveness of removing stones during RIRS (Retrograde Intrarenal Surgery). The vacuum assistance might reduce procedure time and increase stone clearance rates, which could lead to quicker recovery and less discomfort for patients. This method represents a promising advancement in the management of kidney stones, potentially enhancing outcomes compared to the conventional approaches.
What evidence suggests that the ClearPetra device is effective for kidney stones?
Research has shown that the ClearPetra vacuum-assisted ureteral access sheath, used by participants in one arm of this trial, can effectively help remove kidney stones. This device simultaneously breaks down and removes the stones. Early results suggest it might clear stones more efficiently than traditional methods, which participants in the other arm of this trial will undergo. Additionally, by reducing pressure inside the kidney, ClearPetra may lower the risk of infections after the procedure. Although limited data exists specifically for the American population, these features offer promising potential for better outcomes.
Who Is on the Research Team?
Wilson Molina, MD
Principal Investigator
Study Principal Investigator
Are You a Good Fit for This Trial?
This trial is for individuals with kidney stones smaller than 2 cm who are undergoing ureteroscopy. The study aims to include those who can benefit from a new device designed to improve the procedure and potentially reduce postoperative infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo retrograde intrarenal surgery (RIRS) with either the ClearPetra™ vacuum-assisted ureteral access sheath or a traditional approach
Follow-up
Participants are monitored for stone-free status and urinary tract infection postoperatively
What Are the Treatments Tested in This Trial?
Interventions
- ClearPetra™ Vacuum-assisted Ureteral Access Sheath
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor