NCT07492147

Brief 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. 1.Does using negative pressure suction during surgery affect the amount of irrigation fluid absorbed by the patient's body?
  2. 2.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.
  3. 3.Preoperative test results (such as CT scans, ultrasounds, and urine tests).
  4. 4.Intraoperative data (such as surgery duration and the exact amount of fluid absorbed, measured by a monitoring device).
  5. 5.Postoperative recovery data (such as body temperature, pain levels, hospital stay length, and any signs of infection).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Mar 2026Jul 2027

Study Start

First participant enrolled

March 9, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2027

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

March 19, 2026

Last Update Submit

March 19, 2026

Conditions

Kidney Stones

Outcome Measures

Primary Outcomes (1)

  • Volume of irrigation fluid absorbed

    Intraoperative (During the surgery)

Secondary Outcomes (3)

  • Incidence of postoperative fever and infectious complication

    Up to 7 days postoperatively

  • ostoperative length of hospital stay

    From surgery to hospital discharge (an average of 3-7 days)

  • Stone-free rate (SFR)

    1 month postoperatively

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients aged 18 years and older with kidney stones who meet the surgical indications for RIRS;
  • Patients who have provided informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Zhiping Wang

CONTACT

13893131697wangzplzu@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor; Chief Physician

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 7, 2027

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

CN(1)