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Enrolling by Invitation

NCT Number: NCT06938113

Ureteroscopy Combined With Negative Pressure Sheath Treatment of Kidney Stones

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

Primary outcomes

  1. Stone removal rate 1 month after surgery

    Time frame: From enrollment to 1 month after surgery

Secondary outcomes

  1. Immediate stone free rate

    Time frame: From enrollment to 1 day after surgery

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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