ClearPetra™ Vacuum-assisted Ureteral Access Sheath Vs Traditional Approach

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called ClearPetra™, which is a vacuum-assisted ureteral access sheath used during a procedure to remove kidney stones. The trial aims to compare how well this new device works against traditional methods (which might not use a sheath or use a non-vacuum sheath) in helping to clear kidney stones and reduce the chances of infection after the procedure. Ureteroscopy, the procedure being studied, is typically recommended for treating kidney stones that are smaller than 2 centimeters.

To participate in this trial, you need to be at least 18 years old and scheduled for a specific type of surgery to remove kidney stones that are between 1.0 and 2.5 centimeters in size. However, there are some people who cannot join, such as those with certain medical conditions or who are pregnant. If you are eligible and choose to participate, you can expect to help researchers understand how effective the ClearPetra device is, which could lead to better treatment options for kidney stones in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females over18 years of age
• • 2. Undergoing primary flexible ureteroscopy for retrograde intrarenal surgery
• • 3. Total stone burden between 1.0 to 2.5 cm
• Exclusion Criteria:
• • 1. Undergoing bilateral stone treatment during the same procedure
• • 2. Patients with known genitourinary anatomical abnormalities
• • 3. Uncorrected coagulopathy
• • 4. Patients with urinary diversions
• • 5. Chronic external urinary catheters
• • 6. Women who are pregnant
• • 7. Immunosuppressed patients
• • 8. Non-elective procedures