Ureter InjuryNCT06987760
Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones
A study testing flexible ureteroscope urolithiasis in people with Ureter Injury and Urolithiasis; Lower Urinary Tract, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ureter Injury, Urolithiasis; Lower Urinary Tract, Efficacy, Self
- What is being tested?
- flexible ureteroscope urolithiasis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2025to 30 Dec 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Patients with kidney stones or upper ureteral stones with a cumulative diameter of less than 3 cm are selected for ureteral soft lens holmium laser lithotripsy.
- 2.Age 18 to 80 years old, gender unlimited. 3.The subjects have no mental illness or language dysfunction, can understand the situation of the study and can sign informed consent.
Who cannot join
- 1.Patients with a history of ureteral stenosis or who have undergone open or laparoscopic ureteral or renal lithotomy.
- 2.Patients with fever one week before surgery 3.Pregnant women and menstruating patients. 4.Patients with combined systemic disease or inability to tolerate anesthesia. 5.Patients undergoing simultaneous surgery for bilateral upper urinary tract stones.
- 6.Patients with ureteral stent indwelling before surgery. 7.In patients with severe hydronephrosis, the separation of the renal collecting system is greater than 4 cm.
- 8.Patients with renal anatomic malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney.
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
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
Li Fang, Dr, 057487085111, fanyruo@126.com
Boyang Song, Dr, 057487085111, fyysongboyang@nbu.edu.cn
About this study
Official title: Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones - A Randomized Controlled Multi-center Clinical Trials
Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.
Read the detailed description
Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.
- Being tested
- flexible ureteroscope urolithiasis
- Keywords
- Urolithiasis, Ratio of Endoscope-Sheath Diameter, Flexible ureteroscope
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible ureteroscope urolithiasisProcedure or surgery
Using flexible ureteroscope combine with urethral access sheath to treatment urolithiasis
| Study group | Role | What they receive |
|---|---|---|
| 7.5Fr fURS and 10Fr UAS | Experimental | 7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath. Receives: Procedure: flexible ureteroscope urolithiasis |
| 9.0Fr fURS and 12Fr UAS | Active comparator | 9.0Fr disposable electronic flexible ureteroscope combine with 12Fr distally deflectable ureteral access sheath. Receives: Procedure: flexible ureteroscope urolithiasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of ureteral access sheath insertion
Proportion of successful ureteral implantation, success rate = number of successful cases/total number of cases
Measured: From enrollment to completion of surgery
Secondary outcomes (4)
The condition of ureter injury
The ureter was observed at exit of the ureteroscope and graded according to Traxer's proposed grading system.
Measured: 24 hours
Stone clearance rate
Residual stones less than 4 mm are considered to be free of residual stones.
Measured: up to 8 weeks.
Operation time
The duration of the operation from start to finish.
Measured: 24 hours
The incidence of surgical complications
The occurrence of postoperative fever, urogenic sepsis and septic shock
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start19 Mar 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter InjuryStudies 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
- Factorial
- Model description
- 7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Fuyang District, Hangzhou City, The Central Hospital of Lishui City
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987760
- Sponsor's protocol ID
- MNWK202401
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones - A Randomized Controlled Multi-center Clinical Trials
- ClinicalTrials.gov ID
- NCT06987760
- Acronym / sponsor ID
- MNWK202401
- Keywords
- Urolithiasis, Ratio of Endoscope-Sheath Diameter, Flexible ureteroscope
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Collaborators
- The First People's Hospital of Fuyang District, Hangzhou City, The Central Hospital of Lishui City
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 May 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.
Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.
Detailed description
Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath.
| Arm | Type | Receives |
|---|---|---|
| 7.5Fr fURS and 10Fr UAS | Experimental | Procedure: flexible ureteroscope urolithiasis7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath. |
| 9.0Fr fURS and 12Fr UAS | Active comparator | Procedure: flexible ureteroscope urolithiasis9.0Fr disposable electronic flexible ureteroscope combine with 12Fr distally deflectable ureteral access sheath. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.Patients with kidney stones or upper ureteral stones with a cumulative diameter of less than 3 cm are selected for ureteral soft lens holmium laser lithotripsy.
- 2.Age 18 to 80 years old, gender unlimited. 3.The subjects have no mental illness or language dysfunction, can understand the situation of the study and can sign informed consent.
Key exclusion criteria (4 listed)
- 1.Patients with a history of ureteral stenosis or who have undergone open or laparoscopic ureteral or renal lithotomy.
- 2.Patients with fever one week before surgery 3.Pregnant women and menstruating patients. 4.Patients with combined systemic disease or inability to tolerate anesthesia. 5.Patients undergoing simultaneous surgery for bilateral upper urinary tract stones.
- 6.Patients with ureteral stent indwelling before surgery. 7.In patients with severe hydronephrosis, the separation of the renal collecting system is greater than 4 cm.
- 8.Patients with renal anatomic malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney.
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 |
|---|---|---|
| flexible ureteroscope urolithiasisUsing flexible ureteroscope combine with urethral access sheath to treatment urolithiasis | Procedure or surgery | 7.5Fr fURS and 10Fr UAS, 9.0Fr fURS and 12Fr UAS |
Primary outcome
Success rate of ureteral access sheath insertion
Time frame: From enrollment to completion of surgery
Proportion of successful ureteral implantation, success rate = number of successful cases/total number of cases
4 secondary outcomes
The condition of ureter injury
Time frame: 24 hours
Stone clearance rate
Time frame: up to 8 weeks.
Operation time
Time frame: 24 hours
The incidence of surgical complications
Time frame: 7 days
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 23 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flexible ureteroscope urolithiasis in people with Ureter Injury and Urolithiasis; Lower Urinary Tract, run by Ningbo No. 1 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 4 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 23 May 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 Li Fang (+86-13586681743, fanyruo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of ureteral access sheath insertion (time frame: From enrollment to completion of 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 23 May 2025.