UreterolithiasisNCT06841523

An Intelligent Pressure and Temperature Control Ureteral Soft Scope System for Treating Stones With Infection.

A study testing Conventional Ureteroscope in people with Ureterolithiasis and Renal Calculi, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Ureterolithiasis, Renal Calculi
What is being tested?: Conventional Ureteroscope
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 288 participants
Where: 1 siteChina
Study dates: 1 Apr 2025to 1 Apr 2028
Phase: Interventional
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

Who may be able to join

18 ≤ Age ≤ 75 years old, regardless of gender, able to tolerate surgery;
ASA I-III;
Patients who have been confirmed by bilateral renal/urinary tract CT to have upper ureteral or renal stones, single or multiple, with a cumulative maximum diameter of 10mm < cumulative maximum diameter ≤ 20mm, and are planning to undergo ureteroscopic lithotripsy for stone removal;
Confirmed urinary tract infection, indicated by positive urine leukocytes and nitrite, or positive urine culture, with appropriate antibiotic treatment administered preoperatively;
Those who voluntarily participate and sign an informed consent form.

Who cannot join

Uncontrollable systemic hemorrhagic disease;
Severe spinal deformities, severe hip joint deformities, and difficulty in lithotomy position;
Uncontrolled acute urinary tract infections;
Any intracavitary surgery caused by anatomical factors of the urinary system cannot be performed;
Pregnant, planned pregnancy within 3 months, and lactating female patients;
The patients determined by the investigator to be unsuitable for this study include (but are not limited to): known to have human immunodeficiency virus (HIV) or AIDS; Suffering from mental illness; Infectious diseases.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kewei Xu, MD, PhD contact

+86-13632331628

xukewei@mail.sysu.edu.cn

China1 site

Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: Intelligent Pressure and Temperature Control Ureteral Soft Scope System for the Treatment of Upper Ureteral Stones Complicated With Infection in the Kidney and Upper Ureter: a Multicenter Randomized Controlled Clinical Study

The goal of this clinical trial is to determine the efficacy and safety of a novel intelligent pressure and temperature-controlled ureteroscope system for treating renal and upper ureteral stones with concurrent infection. It will also assess its ability to reduce postoperative complications and improve stone clearance rates. The main questions it aims to answer are:

Does the intelligent system lower the complication rate and enhance stone clearance compared to standard ureteroscopy? What safety issues or medical problems do participants experience when using the intelligent system? Researchers will compare the intelligent pressure and temperature-controlled ureteroscope system to a standard ureteroscope to evaluate its effectiveness in treating renal and upper ureteral stones.

Participants will:

Undergo surgery using either the intelligent system or a standard ureteroscope Be monitored for postoperative complications, stone clearance, and other relevant outcomes Participate in follow-up visits to assess recovery and treatment efficacy

Read the detailed description

This study protocol describes a multi-center, prospective, randomized controlled trial with a non-inferiority design, aiming to assess the efficacy and safety of an intelligent pressure and temperature-controlled ureteroscope system for treating renal and upper ureteral stones with concurrent infection. A total of 288 patients will be randomized into two groups (1:1 ratio), with the intervention group receiving the intelligent system and the control group undergoing standard ureteroscopy. The primary endpoints are the complication rate and stone clearance rate at 1 month postoperatively, while secondary endpoints include short-term stone clearance, intraoperative and postoperative complications, infection markers, surgical time, and intraoperative pressure and temperature monitoring. The study will adhere to rigorous ethical standards and statistical analysis plans to provide robust evidence for the clinical application of this novel device.

Conditions: Ureterolithiasis, Renal Calculi
Being tested: Intelligent Pressure and Temperature-Controlled Ureteroscope System, Conventional Ureteroscope
Keywords: Ureteral Stone, renal stone, Ureteroscopy, Upper urinary tract stones with concurrent infection
Medical subject headings: Ureterolithiasis, Kidney Calculi, Nephrolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intelligent Pressure and Temperature-Controlled Ureteroscope SystemDevice
RIRS procedure for upper ureteral or renal stone lithotripsy with Intelligent Pressure and Temperature-Controlled Ureteroscope System
Conventional UreteroscopeDevice
RIRS procedure for upper ureteral or renal stone lithotripsy with conventional ureteroscope

Study groups in NCT06841523
Study group	Role	What they receive
Intelligent Pressure and Temperature-Controlled Ureteroscope System	Active comparator	Participants in this arm will undergo surgery using the Intelligent Pressure and Temperature-Controlled Ureteroscope System, which monitors and adjusts intrarenal pressure and temperature in real-time to ensure safe and effective lithotripsy. Receives: Device: Intelligent Pressure and Temperature-Controlled Ureteroscope System
Conventional Ureteroscope	Active comparator	Participants assigned to this arm will undergo surgery with a conventional ureteroscope. The procedure involves standard ureteroscopic lithotripsy without real-time pressure or temperature monitoring. Receives: Device: Conventional Ureteroscope

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Complication Rate
This composite outcome measure includes the incidence of the following complications:
1. Fever: Defined as body temperature ≥38℃.
2. Urinary Sepsis: An increase in the Sequential Organ Failure Assessment (SOFA) score by ≥2 points postoperatively.
3. Septic Shock: Requires vasopressors to maintain mean arterial pressure ≥65 mmHg after adequate fluid resuscitation, with blood lactate concentration >2 mmol/L
4. Pain: Assessed using the Numeric Rating Scale (NRS) within 48 hours postoperatively, recording the need for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) or other analgesic treatment.
5. Renal subcapsular or perirenal hematomaL: Diagnosed by Computed Tomography (CT) or other imaging within 30 days postoperatively.
The composite postoperative complication rate will be calculated as the number of patients with at least one complication divided by the total number of patients in the study, multiplied by 100 to obtain a percentage.
Measured: Assessed at 48 hours and 1 month postoperatively.
Stone Free Rate
This is defined as the proportion of patients with no residual stones or residual stones ≤2mm in diameter and asymptomatic, as confirmed by renal CT at 1 month postoperatively.
Measured: Assessed at 1 month postoperatively.

Secondary outcomes (7)

Stone Clearance Rate at 48 hours postoperatively
The proportion of patients with no residual stones or residual stones ≤2mm in diameter and asymptomatic, as confirmed by renal CT at 48 hours postoperatively.
Measured: Assessed at 48 hours postoperatively.
Intraoperative Complications Rate
The incidence of intraoperative complications, including ureteral or renal pelvis perforation, ureteral mucosal stripping, ureteral rupture, the need for conversion to other treatments, and failure of ureteral access sheath placement.
Measured: Assessed at 2 hours after the surgical procedure.
Concentration of postoperative infection markers
Changes in the concentration of postoperative infection markers Procalcitonin (PCT) and C-reactive protein (CRP), hemoglobin (Hb), serum creatinine (Scr), and blood urea nitrogen (BUN).
Measured: Assessed at 48 hours postoperatively during hospitalization.
Intraoperative Pressure
The intraoperative pressure values recorded during the procedure measured by the intelligent pressure and temperature control ureteral soft scope system.
Measured: Assessed 2 hours after the surgical procedure.
Intraoperative Temperature
The intraoperative temperature values recorded during the procedure.
Measured: Assessed at 2 hours after the surgical procedure.
Postoperative Hospital Stay
The length of hospital stay following the surgical procedure.
Measured: Assessed at 24 hours after patients leaving the hospital
Surgical and Lithotripsy Time
The duration of the surgical procedure and the time required for lithotripsy.
Measured: Assessed at 24 hours postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20251 Apr 2028

First posted24 Feb 2025
Study start1 Apr 2025 (estimated)
Primary completion1 Apr 2028 (estimated)
Study completion1 Apr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for UreterolithiasisStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Arm 1: Intelligent Pressure and Temperature-Controlled Ureteroscope System Arm 2: Conventional Ureteroscope
Masking: Single blind
Who is masked: Participant
Enrolment: 288 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06841523
Sponsor's protocol ID: SYSKY-2024-1120-02
Status last verified: Mar 2025
First submitted: 9 Feb 2025
Last updated: 7 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Kewei Xu, MD, PhD

+86-13632331628

xukewei@mail.sysu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
The Effect of Acupuncture on Passing Ureteral Stones
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Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
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Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)
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Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
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All Ureterolithiasis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intelligent Pressure and Temperature Control Ureteral Soft Scope System for the Treatment of Upper Ureteral Stones Complicated With Infection in the Kidney and Upper Ureter: a Multicenter Randomized Controlled Clinical Study
ClinicalTrials.gov ID: NCT06841523
Acronym / sponsor ID: SYSKY-2024-1120-02
Conditions: Ureterolithiasis, Renal Calculi
Keywords: Ureteral Stone, renal stone, Ureteroscopy, Upper urinary tract stones with concurrent infection
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 288 participants (estimated)
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
Study start: 1 Apr 2025 (estimated)
Primary completion: 1 Apr 2028 (estimated)
Study completion: 1 Apr 2028 (estimated)
First posted: 24 Feb 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.

Participants will:

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Arm 1: Intelligent Pressure and Temperature-Controlled Ureteroscope System Arm 2: Conventional Ureteroscope

Arm	Type	Receives
Intelligent Pressure and Temperature-Controlled Ureteroscope System	Active comparator	Device: Intelligent Pressure and Temperature-Controlled Ureteroscope SystemParticipants in this arm will undergo surgery using the Intelligent Pressure and Temperature-Controlled Ureteroscope System, which monitors and adjusts intrarenal pressure and temperature in real-time to ensure safe and effective lithotripsy.
Conventional Ureteroscope	Active comparator	Device: Conventional UreteroscopeParticipants assigned to this arm will undergo surgery with a conventional ureteroscope. The procedure involves standard ureteroscopic lithotripsy without real-time pressure or temperature monitoring.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18 ≤ Age ≤ 75 years old, regardless of gender, able to tolerate surgery;
ASA I-III;
Patients who have been confirmed by bilateral renal/urinary tract CT to have upper ureteral or renal stones, single or multiple, with a cumulative maximum diameter of 10mm < cumulative maximum diameter ≤ 20mm, and are planning to undergo ureteroscopic lithotripsy for stone removal;
Confirmed urinary tract infection, indicated by positive urine leukocytes and nitrite, or positive urine culture, with appropriate antibiotic treatment administered preoperatively;
Those who voluntarily participate and sign an informed consent form.

Key exclusion criteria (6 listed)

Uncontrollable systemic hemorrhagic disease;
Severe spinal deformities, severe hip joint deformities, and difficulty in lithotomy position;
Uncontrolled acute urinary tract infections;
Any intracavitary surgery caused by anatomical factors of the urinary system cannot be performed;
Pregnant, planned pregnancy within 3 months, and lactating female patients;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intelligent Pressure and Temperature-Controlled Ureteroscope SystemRIRS procedure for upper ureteral or renal stone lithotripsy with Intelligent Pressure and Temperature-Controlled Ureteroscope System	Device	Intelligent Pressure and Temperature-Controlled Ureteroscope System
Conventional UreteroscopeRIRS procedure for upper ureteral or renal stone lithotripsy with conventional ureteroscope	Device	Conventional Ureteroscope

Primary outcome

Postoperative Complication Rate
Time frame: Assessed at 48 hours and 1 month postoperatively.
This composite outcome measure includes the incidence of the following complications: 1. Fever: Defined as body temperature ≥38℃. 2. Urinary Sepsis: An increase in the Sequential Organ Failure Assessment (SOFA) score by ≥2 points postoperatively. 3. Septic Shock: Requires vasopressors to maintain mean arterial pressure ≥65 mmHg after adequate fluid resuscitation, with blood lactate concentration >2 mmol/L 4. Pain: Assessed using the Numeric Rating Scale (NRS) within 48 hours postoperatively, recording the need for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) or other analgesic treatment. 5. Renal subcapsular or perirenal hematomaL: Diagnosed by Computed Tomography (CT) or other imaging within 30 days postoperatively. The composite postoperative complication rate will be calculated as the number of patients with at least one complication divided by the total number of patients in the study, multiplied by 100 to obtain a percentage.
Stone Free Rate
Time frame: Assessed at 1 month postoperatively.
This is defined as the proportion of patients with no residual stones or residual stones ≤2mm in diameter and asymptomatic, as confirmed by renal CT at 1 month postoperatively.

7 secondary outcomes

Stone Clearance Rate at 48 hours postoperatively
Time frame: Assessed at 48 hours postoperatively.
Intraoperative Complications Rate
Time frame: Assessed at 2 hours after the surgical procedure.
Concentration of postoperative infection markers
Time frame: Assessed at 48 hours postoperatively during hospitalization.
Intraoperative Pressure
Time frame: Assessed 2 hours after the surgical procedure.
Intraoperative Temperature
Time frame: Assessed at 2 hours after the surgical procedure.
Postoperative Hospital Stay
Time frame: Assessed at 24 hours after patients leaving the hospital
Surgical and Lithotripsy Time
Time frame: Assessed at 24 hours 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 7 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Ureterolithiasis

Recruiting
The Effect of Acupuncture on Passing Ureteral Stones
Ureter Calculi
Active, not recruiting
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
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Recruiting
Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)
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RecruitingPhase 4
Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
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Recruiting
UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones
Ureteral Stone

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.

Kewei Xu, MD, PhD contact

+86-13632331628

xukewei@mail.sysu.edu.cn

Kewei Xu, MD, PhD principal investigator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Ureteroscope in people with Ureterolithiasis and Renal Calculi, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 6 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: opening soon, as of the sponsor's last update on 7 Mar 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?

Contact Kewei Xu, MD, PhD (+86-13632331628, xukewei@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Complication Rate (time frame: Assessed at 48 hours and 1 month postoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06841523.

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 7 Mar 2025.