Ureteroscopy Combined With Negative Pressure Sheath Treatment of Kidney Stones

• Conditions: Kidney Calculi

• Registration Number: NCT06938113
• Lead Sponsor: Peking University First Hospital

Brief 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, what is the safety and effectiveness of ureteral soft scope combined with negative pressure suction sheath treatment for patients with high-load kidney stones and stones combined with infection? This study will help to solve the problems of safety and effectiveness of ureteral soft scope combined with negative pressure aspiration in the treatment of high-load kidney stones and kidney stones combined with infection, provide a more scientific treatment strategy for clinical practice, and promote the application of negative pressure aspiration technology in the field of ureteral soft scope lithotripsy, providing new means and ideas for individualized treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-03
• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-20
• Last Update Submitted: 2025-04-20
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

150/5000

1. Patients diagnosed with kidney stones with a diameter of 2-3cm by CT;
2. Age > 18 years old;
3. The anatomical structure of the kidney is normal, without deformity;
4. Unilateral or bilateral kidney stones are not treated at the same time
5. No serious heart and lung disease (ASA grade I-II)
6. Through preoperative communication, patients and their family members indicated that they were fully aware of the condition and the choice of treatment plan, and signed informed consent and informed choice notification;

Exclusion Criteria

1. Simultaneous operation is required for ipsilateral ureteral calculi or contralateral upper or lower urinary calculi.
2. Severe coagulation dysfunction;
3. Previous history of ipsilateral upper urinary tract surgery;
4. Presence of urinary anatomic abnormalities or congenital malformations;
5. Patients who do not sign informed consent and cannot cooperate with the study;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stone removal rate 1 month after surgery	From enrollment to 1 month after surgery

Secondary Outcome Measures

Name	Time	Method
Immediate stone free rate	From enrollment to 1 day after surgery

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China