Kidney StonesNCT07492147
Effect of Negative Pressure Suction on Fluid Absorption and Infection in Flexible Ureteroscopy
An observational study of Kidney Stones, run by Lanzhou University Second Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the effects of using negative pressure suction during retrograde intrarenal surgery (RIRS) in patients aged 18 and older with kidney stones. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2026to 7 Jul 2027
- How long will I take part?
- 7 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (typically aged 18 years and older) diagnosed with renal and/or upper ureteral stones who are scheduled to undergo retrograde intrarenal surgery (RIRS) at the urology department.
Who may be able to join
- Patients aged 18 years and older with kidney stones who meet the surgical indications for RIRS;
- Patients who have provided informed consent.
Who cannot join
- Concurrent combination with other surgical procedures, such as percutaneous nephrolithotomy (PCNL);
- Patients with malignancies, urinary tuberculosis, immune system diseases, or hyperthyroidism;
- Congenital renal anomalies, such as polycystic kidney disease or horseshoe kidney;
- Presence of untreated urinary tract infections;
- Inability to tolerate surgery due to severe cardiopulmonary dysfunction, hepatic or renal insufficiency, or coagulation abnormalities.
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, 1 recruiting
- Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Guilin Wang, 18386255271, wangglin5@126.com
About this study
Official title: Impact of Negative Pressure Suction on Irrigation Fluid Absorption and Postoperative Infection Risk During Flexible Ureteroscopic Lithotripsy: A Prospective Cohort Study
The goal of this observational study is to learn about the effects of using negative pressure suction during retrograde intrarenal surgery (RIRS) in patients aged 18 and older with kidney stones. The main questions it aims to answer are:
- Does using negative pressure suction during surgery affect the amount of irrigation fluid absorbed by the patient's body?
- Does using negative pressure suction reduce the risk of postoperative infections, such as fever, systemic inflammatory response syndrome (SIRS), and urosepsis? Researchers will compare patients who undergo surgery with a negative pressure suction sheath to patients who undergo surgery with a standard sheath (without suction) to see if the suction technology reduces fluid absorption and lowers the risk of postoperative complications.
Read more
Participants will undergo their scheduled kidney stone surgery as part of their regular medical care. Researchers will collect their routine clinical data from the hospital system, including:
- Preoperative test results (such as CT scans, ultrasounds, and urine tests).
- Intraoperative data (such as surgery duration and the exact amount of fluid absorbed, measured by a monitoring device).
- Postoperative recovery data (such as body temperature, pain levels, hospital stay length, and any signs of infection).
- Conditions
- Kidney Stones
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Suction Sheath Group | Patients who undergo retrograde intrarenal surgery (RIRS) using a ureteral access sheath with a negative pressure suction system. | |
| Standard Ureteral Access Sheath Group | Patients who undergo retrograde intrarenal surgery (RIRS) using a standard ureteral access sheath without a negative pressure suction system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of irrigation fluid absorbed
Measured: Intraoperative (During the surgery)
Secondary outcomes (3)
Incidence of postoperative fever and infectious complication
Measured: Up to 7 days postoperatively
ostoperative length of hospital stay
Measured: From surgery to hospital discharge (an average of 3-7 days)
Stone-free rate (SFR)
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start9 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- 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
- 400 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Lanzhou University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiping Wang, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492147
- Sponsor's protocol ID
- 2025A-1369
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The clinical data involves sensitive patient privacy. We are currently undecided on sharing the IPD, as it requires specific informed consent from the patients and authorization from the hospital's ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Negative Pressure Suction on Irrigation Fluid Absorption and Postoperative Infection Risk During Flexible Ureteroscopic Lithotripsy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07492147
- Acronym / sponsor ID
- 2025A-1369
- Conditions
- Kidney Stones
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Lanzhou University Second HospitalUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 25 Mar 2026 (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 goal of this observational study is to learn about the effects of using negative pressure suction during retrograde intrarenal surgery (RIRS) in patients aged 18 and older with kidney stones. The main questions it aims to answer are:
- Does using negative pressure suction during surgery affect the amount of irrigation fluid absorbed by the patient's body?
- Does using negative pressure suction reduce the risk of postoperative infections, such as fever, systemic inflammatory response syndrome (SIRS), and urosepsis? Researchers will compare patients who undergo surgery with a negative pressure suction sheath to patients who undergo surgery with a standard sheath (without suction) to see if the suction technology reduces fluid absorption and lowers the risk of postoperative complications.
Participants will undergo their scheduled kidney stone surgery as part of their regular medical care. Researchers will collect their routine clinical data from the hospital system, including:
- Preoperative test results (such as CT scans, ultrasounds, and urine tests).
- Intraoperative data (such as surgery duration and the exact amount of fluid absorbed, measured by a monitoring device).
- Postoperative recovery data (such as body temperature, pain levels, hospital stay length, and any signs of infection).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Suction Sheath Group | – | –Patients who undergo retrograde intrarenal surgery (RIRS) using a ureteral access sheath with a negative pressure suction system. |
| Standard Ureteral Access Sheath Group | – | –Patients who undergo retrograde intrarenal surgery (RIRS) using a standard ureteral access sheath without a negative pressure suction system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (typically aged 18 years and older) diagnosed with renal and/or upper ureteral stones who are scheduled to undergo retrograde intrarenal surgery (RIRS) at the urology department.
Key inclusion criteria (2 listed)
- Patients aged 18 years and older with kidney stones who meet the surgical indications for RIRS;
- Patients who have provided informed consent.
Key exclusion criteria (5 listed)
- Concurrent combination with other surgical procedures, such as percutaneous nephrolithotomy (PCNL);
- Patients with malignancies, urinary tuberculosis, immune system diseases, or hyperthyroidism;
- Congenital renal anomalies, such as polycystic kidney disease or horseshoe kidney;
- Presence of untreated urinary tract infections;
- Inability to tolerate surgery due to severe cardiopulmonary dysfunction, hepatic or renal insufficiency, or coagulation abnormalities.
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
Volume of irrigation fluid absorbed
Time frame: Intraoperative (During the surgery)
3 secondary outcomes
Incidence of postoperative fever and infectious complication
Time frame: Up to 7 days postoperatively
ostoperative length of hospital stay
Time frame: From surgery to hospital discharge (an average of 3-7 days)
Stone-free rate (SFR)
Time frame: 1 month postoperatively
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 25 Mar 2026.
- Individual participant dataSharing planned: Undecided. The clinical data involves sensitive patient privacy. We are currently undecided on sharing the IPD, as it requires specific informed consent from the patients and authorization from the hospital's ethics committee.
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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.
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 Stones, run by Lanzhou University Second 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. 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?
Contact Zhiping Wang (13893131697, wangzplzu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of irrigation fluid absorbed (time frame: Intraoperative (During the 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 25 Mar 2026.