RecruitingNot ApplicableNCT06547632

ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach

ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach in Retrograde Intrarenal Surgery. A Randomized Controlled Trial


Sponsor

University of Kansas Medical Center

Enrollment

150 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Ureteroscopy has been considered the best approach when treating renal stones smaller than 2 cm. This procedure is usually performed together with ureteral access sheaths, which helps protect the ureter mucosa and lowers intrarenal pressure. Recently, a new vacuum-assisted ureteral access sheath called ClearPetra has entered US market and allows for continuous stone fragmentation and aspiration. Because there is little information on comparing this device with traditional approach (no sheath or non-vacuum-assisted sheath) in American population, we aim to compare those devices in terms of their ability to clear the kidney from kidney stones, as well as reduce infection rates postoperatively.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Males or females over18 years of age
  • Undergoing primary flexible ureteroscopy for retrograde intrarenal surgery
  • Total stone burden between 1.0 to 2.5 cm

Exclusion Criteria8

  • Undergoing bilateral stone treatment during the same procedure
  • Patients with known genitourinary anatomical abnormalities
  • Uncorrected coagulopathy
  • Patients with urinary diversions
  • Chronic external urinary catheters
  • Women who are pregnant
  • Immunosuppressed patients
  • Non-elective procedures

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Interventions

DEVICEClearPetra Ureteral access sheath

Patients will be randomly assigned (1:1) to vacuum-assisted (ClearPetra) or traditional approach group for retrograde intrarenal surgery according to standard of care.


Locations(1)

University of Kansas Medical Center

Kansas City, Kansas, United States

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NCT06547632


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