Ureteroscopy Combined With Negative Pressure Sheath Treatment of Kidney Stones

NCT06938113 | Enrolling By Invitation

• 1 other identifier: NP-URL
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Kidney Calculi

Outcome Measures

Primary Outcomes (1)

• Stone removal rate 1 month after surgery

  From enrollment to 1 month after surgery

Secondary Outcomes (1)

• Immediate stone free rate

  From enrollment to 1 day after surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age range from 18 to 75 years old; Patients undergoing flexible ureteroscopy lithotripsy in our hospital due to high-load kidney stones(2-3cm); All enrolled patients received informed consent and signed informed consent before operation.

You may qualify if:

• Patients diagnosed with kidney stones with a diameter of 2-3cm by computed tomography;
• Age \> 18 years old;
• The anatomical structure of the kidney is normal, without deformity;
• No serious heart and lung disease (ASA grade I-III)
• 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;

You may not qualify if:

• Simultaneous operation is required for ipsilateral ureteral calculi or contralateral upper or lower urinary calculi.
• Severe coagulation dysfunction;
• Patients who do not sign informed consent and cannot cooperate with the study;

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 22, 2025
• Study Start: July 28, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-05

Locations

CN (1)