Suspended

Safety and Efficacy of Suctioning Flexible Ureteroscopy With Automatic Control of Renal Pelvic Pressure : A Clinical Randomized,Controlled Study

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What is being tested

SF-URS with automatic control of RPP

+ conventional F-URS

Device
Who is being recruted

Urogenital Diseases+10

+ Calculi

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 75 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: May 2016
See protocol details

Summary

Principal SponsorThe Affiliated Ganzhou Hospital of Nanchang University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2016

Actual date on which the first participant was enrolled.

Retrograde intrarenal surgery using flexible ureteroscope has become the first-line treatment for renal calculi < 3.0 cm and is recommended by the European Association of Urology due to its minimally-invasive nature and satisfactory result. However, high perfusion rate leads to renal pelvic pressure increase, resulting in absorption of liquid, bacteria, and endotoxin into blood, followed by short-term complications such as systemic inflammatory response syndrome(SIRS , 8.1%), sepsis (0-4.5%), renal pelvic and ureteral tumor spread, and long-term complication of renal function impairment. Currently the commonly used flexible ureteroscope sheath (ureteral access sheath, UAS) reduces the renal pelvic pressure to a certain extent, but still can not control and monitor the renal pelvic pressure to reduce the incidence of complications, which, limit the clinical application of ureteroscopy. Recently, the investigators present a novel technique of SF-URS with automatic control of renal pelvic pressure. In this study, transverse comparison is designed to evaluate the safety and efficacy of the suctioning flexible ureteroscopy with automatic control of renal pelvic pressure for the treatment of renal calculi.

Official TitleSafety and Efficacy of Suctioning Flexible Ureteroscopy With Automatic Control of Renal Pelvic Pressure : A Clinical Randomized,Controlled Study
NCT02734914
Principal SponsorThe Affiliated Ganzhou Hospital of Nanchang University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesCalculiFemale Urogenital Diseases and Pregnancy ComplicationsKidney CalculiKidney DiseasesPathological Conditions, Signs and SymptomsUrinary CalculiUrologic DiseasesPathological Conditions, AnatomicalFemale Urogenital DiseasesMale Urogenital DiseasesUrolithiasisNephrolithiasis

Criteria

5 inclusion criteria required to participate
Subject has provided informed consent and indicated a willingness to comply with study treatments

Subject has a diagnosis of renal stones according to computer tomography (CT) results

Subject is 18-75 yrs of age

Subject has a single stone < 3 cm in size, or multiple stones < 3 cm in cumulative size

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9 exclusion criteria prevent from participating
The patient who do not agree with the intention of the clinical study.

Subject needs bilateral procedures within one-stage ureteroscopy

Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.) and severe hematuria

Subject has been diagnosed with a urethral stricture or bladder neck contracture

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in SF-URS with automatic control of renal pelvic pressure (RPP) group undergo ureteroscopy using the intelligent pressure control device (Medical irrigation and suctioning platform with pressure feedback function, and suctioning ureteral access sheath with function of pressure measuring).

Group II

Active Comparator
Participants in conventional F-URS group undergo ureteroscopy using the classic flexible ureteroscope.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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