NCT06547632

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Retrograde intrarenal surgery (RIRS) is now considered gold-standard for treatment of renal stones smaller than 2 cm. This procedure often employs a ureteral access sheath (UAS), as it helps to reduce intrarenal pressure and protects the ureter mucosa when basketing is required. However, the challenge imposed by residual stone fragments and sepsis remains. Additionally, natural elimination of residual stone fragments may induce renal colic, hematuria an even the potential for new stone development. Recently, a new vacuum-assisted ureteral access sheath (VA-UAS) named ClearPetra™ provides concomitant stone fragmentation and aspiration. The new ClearPetra™ vacuum assisted ureteral access sheath allows simultaneous fragmentation and extraction of stones. It is a disposable access sheath equipped with a continuous flow aspiration mechanism. Previous studies have demonstrated the safety and effectiveness of ClearPetra™ in RIRS Comprehensive comparative investigations between ClearPetra™ and traditional UAS in RIRS are lacking in American population. We aim to compare the outcomes of using VA-UAS (ClearPetra™) or traditional approach (no sheath or non-vacuum-assisted sheath) to treat patients with stone burden between 1.0 - 2.5 cm.

Conditions

• Nephrolithiasis
• Kidney Stone

Interventions

Type	Name	Description
DEVICE	ClearPetra 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.

Timeline

• Start date: 2025-07-31
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-08-09
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study