NCT06938113

Ureteroscopy Combined With Negative Pressure Sheath Treatment of Kidney Stones

Efficacy and Safety of Flexible Ureteroscope Combined With Flexible Vacuum-assisted Sheath for Intelligent Pressure Control in the Treatment of Kidney Stones

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 115 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The removal rate, complication risk and operation time of ureteral soft scope combined with negative pressure suction sheath therapy for patients with high-load kidney stones (2-3cm) are still controversial. Therefore, the safety and effectiveness of flexible ureteroscope combined with negative pressure suction sheath in treating patients with high-load kidney stones is unknown. This study will help to solve the problems, provide a more scientific treatment strategy for clinical practice, and promote the application of negative pressure aspiration technology in the field of flexible ureteroscopy lithotripsy, providing new means and ideas for individualized treatment.

Detailed description

The patients enrolled in the group should complete the routine clinical diagnosis and treatment before the operation, including non-contrast CT scan of the urinary system (before surgery), urine routine, urine culture, etc. The postoperative follow-up mainly includes complications after the operation, the time of removing the D-J tube, the time of removing the urinary catheter, urine routine, urine culture, etc. The blood routine, blood chemistry, etc. should be reexamined in the outpatient department one month (4 weeks) after the operation.Patients underwent low-dose CT (DLP:0.45 mGy·cm) scans on the first day and one month after surgery. During the operation, we will collect some data, including the time when invasive procedures start, the total operation time, the renal pelvis pressure, laser power, and total laser energy; we will also keep a backup of the operation video.

Conditions

• Kidney Calculi

Timeline

• Start date: 2025-07-28
• Primary completion: 2025-12-31
• Completion: 2026-01-31
• First posted: 2025-04-22
• Last updated: 2025-09-02

Locations

1 site across 1 country: China