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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Contact Information
Primary
Jane Ledesma
jledesma2@kumc.edu
19135888721
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 150
Treatments
Active_comparator: 1. RIRS WITH VACUUM-ASSISTED URETERAL ACCESS SHEATH
In Arm 1, participants will undergo RIRS with ClearPetra™ vacuum-assisted ureteral access sheath.~Participants will undergo RIRS per standard of care.
No_intervention: 2. RIRS WITH TRADITIONAL APPROACH
In Arm 2, participants will undergo RIRS a traditional approach (no sheath or non-vacuum-assisted sheath). The treating investigator will decide whether to use a regular UAS based on their preference and/or availability.~* No ureteral access sheath~* Navigator™ Ureteral Access Sheath 11/13 Fr (Boston Scientific®)~* Navigator™ Ureteral Access Sheath 12/14 Fr (Boston Scientific®)
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov