CClinicalTrials.gg
Enrolling by invitationNCT06938113Updated Sep 2, 2025

Ureteroscopy Combined With Negative Pressure Sheath Treatment of Kidney Stones

An observational study in Kidney Calculi, sponsored by Peking University First Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Peking University First Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
115
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Kidney Calculi

Browse trials for

03

In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's planned enrollment of 115 is below the median of 144 across 110 observational studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  1. Patients diagnosed with kidney stones with a diameter of 2-3cm by computed tomography;
  2. Age > 18 years old;
  3. The anatomical structure of the kidney is normal, without deformity;
  4. No serious heart and lung disease (ASA grade I-III)
  5. 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

Exclusion Criteria:

  1. Simultaneous operation is required for ipsilateral ureteral calculi or contralateral upper or lower urinary calculi.
  2. Severe coagulation dysfunction;
  3. Patients who do not sign informed consent and cannot cooperate with the study;
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
115 participants (estimated)
Patient registry
No
06

What researchers measure

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

07

Study locations

1 site
  • Peking University First Hospital
    Beijing, Beijing Municipality 100034, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06938113
Lead sponsor
Peking University First Hospital
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
Jul 28, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Sep 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion