First Prospective, In Vivo Experience Using a Novel Steerable Suction Ureteral Access Sheath in North America

Area of Science:

• Urology
• Minimally Invasive Surgery
• Endourology

Background:

• Flexible ureteroscopy is a common procedure for treating kidney stones.
• Traditional ureteral access sheaths (UAS) can be challenging to navigate, especially in cases of aberrant anatomy.
• Novel devices are needed to improve the safety and efficacy of ureteroscopy.

Purpose of the Study:

• To evaluate the initial clinical experience with the ClearPetra UAS, a new flexible and navigable suction (FANS) device, in North America.
• To assess the safety and effectiveness of the ClearPetra UAS in patients undergoing flexible ureteroscopy for renal stone treatment.

Main Methods:

• A prospective, single-center study enrolled 87 consecutive patients requiring flexible ureteroscopy for renal stone treatment.
• The ClearPetra UAS was used instead of traditional UAS.
• Preoperative stone volumes were measured by non-contrast CT (NCCT) and semiautomated segmentation (qSAS).

Main Results:

• The ClearPetra UAS was successfully used in all 87 patients, including those with aberrant anatomy.
• Mean stone volume reduction was 89.8% among 42 eligible patients.
• Ureteral injury occurred in 9 cases (8 Traxer Grade 1-2, 1 Grade 3).

Conclusions:

• The ClearPetra UAS is safe and effective for ureteroscopy in North America.
• The device demonstrated acceptable postoperative complication rates and stone-free status.
• This study represents the first North American experience with the ClearPetra UAS, including patients with aberrant anatomy.