Kidney CalculiNCT06938113
Ureteroscopy Combined With Negative Pressure Sheath Treatment of Kidney Stones
An observational study of Kidney Calculi, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Calculi
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Efficacy and Safety of Flexible Ureteroscope Combined With Flexible Vacuum-assisted Sheath for Intelligent Pressure Control in the 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.
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.
- Conditions
- Kidney Calculi
- Medical subject headings
- Kidney Calculi
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone removal rate 1 month after surgery
Measured: From enrollment to 1 month after surgery
Secondary outcomes (1)
Immediate stone free rate
Measured: From enrollment to 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start28 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938113
- Sponsor's protocol ID
- NP-URL
- Status last verified
- May 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Flexible Ureteroscope Combined With Flexible Vacuum-assisted Sheath for Intelligent Pressure Control in the Treatment of Kidney Stones
- ClinicalTrials.gov ID
- NCT06938113
- Acronym / sponsor ID
- NP-URL
- Conditions
- Kidney Calculi
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stone removal rate 1 month after surgery
Time frame: From enrollment to 1 month after surgery
1 secondary outcome
Immediate stone free rate
Time frame: From enrollment to 1 day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Calculi, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone removal rate 1 month after surgery (time frame: From enrollment to 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.