Urinary CalculiSFUUTSNCT05712785
Shuotongo Ureteroscopy for Upper Urinary Tract Stones
A study testing Use of shuotong ureteroscopy in people with Urinary Calculi and Ureterocele, run by Handan First Hospital at 1 site in China.
Trial summary
The purpose of this study is to use the Shuotong ureteroscopy for surgical treatment of patients with upper urinary tract stones, taking advantage of the fact that the Shuotong mirror can be used for simultaneous lithotripsy and stone removal, thus maximizing the discharge of stones from the body and improving the… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Calculi, Ureterocele
- What is being tested?
- Use of shuotong ureteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 20 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Ureteral calculus Must be able to cooperate with the treatment
Who cannot join
- Patients had severe urinary tract infections; patients had other conditions which investigators thought not suitable for the study.
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
Kunwu Yan
Handan, Hebei, 056000
kunwu yan, Master, +8618232053937, 1749200794@qq.com
xiaofei tian, Master, +8615233882780, fei19860703@126.com
About this study
Official title: Clinical Study on the Treatment of Upper Urinary Tract Stones by Shuotong Scope
The purpose of this study is to use the Shuotong ureteroscopy for surgical treatment of patients with upper urinary tract stones, taking advantage of the fact that the Shuotong mirror can be used for simultaneous lithotripsy and stone removal, thus maximizing the discharge of stones from the body and improving the stone removal rate.
Read the detailed description
Ureteroscopy via the natural lumen has the advantages of being non-invasive, safe and repeatable. This is where Shuotongo ureteroscopy, a new type of ureteroscopy, has not yet become fully popular. Usually, most patients with upper urinary tract stones are treated by ureteroscopy or with flexible ureteroscopy, because these endoscopes usually break the stones and ask the patient to drink more water to expel the stones by themselves, after the operation, it is usually easy to leave stones in the body, and some patients even form stone streets to block the ureter again after the operation. In some patients, stones may form again and obstruct the ureter again. The Shuotong Ureteroscopy has the advantages of stone crushing and stone removal, which can synchronize the process of stone crushing and stone removal and maintain a good surgical view. It has the advantages of simple operation, less trauma and high safety for the operation via natural channel, especially for the large stones in the upper urinary tract and Gantun stones.
- Conditions
- Urinary Calculi, Ureterocele
- Being tested
- Use of shuotong ureteroscopy
- Medical subject headings
- Urinary Calculi, Ureterocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of shuotong ureteroscopyDevice
Treatment of patients with ureteral stones using the Shuotong-scopy
| Study group | Role | What they receive |
|---|---|---|
| Shuotong Ureteroscopy group | Experimental | Shuotong Ureteroscopy: a ureteroscope that can lithotripsy and lithotripsy simultaneously Receives: Device: Use of shuotong ureteroscopy |
| Ureteroscopy group | No intervention | Ureteroscopy group：using conventional ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone removal rate
Residual stones in the body after surgery
Measured: 1 week after surgery
Secondary outcomes (1)
Surgery time
Time from start of surgery to end of surgery
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Jan 2020
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary CalculiStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Handan First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kunwu-yan, Handan First Hospital
- Investigators
- kunwu yan, Master, Principal investigator, Handan First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712785
- Sponsor's protocol ID
- 20231925-1
- Acronym
- SFUUTS
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lai L, Zhang W, Zheng F, Wang T, Bai P, Liu Z, Zheng J, Shao Z, Duan B, Wang H, Xing J, Chen H, Huang Y, Chen B. Comparison of the Efficacy of ShuoTong Ureteroscopy and Simple Flexible Ureteroscopy in the Treatment of Unilateral Upper Ureteral Calculi. Front Surg. 2021 Sep 27;8:707022. doi: 10.3389/fsurg.2021.707022. eCollection 2021.
PubMed 34646858Qiao D, Cheng L, Xiaomei T, Baolei S, Yingyi L, Hui Z, Shaohua B, Wei L, U DY, Fangqiong D, Jie L, Shuangning L. Effect of ultra-mini percutaneous nephrolithotomy and ShuoTong ureteroscopy on the stress response, inflammatory indices, and urokinase level in patients with polycystic kidney disease complicated with renal calculus. Cell Mol Biol (Noisy-le-grand). 2022 Feb 4;67(5):309-316. doi: 10.14715/cmb/2021.67.5.42.
PubMed 35818238Gan S, Guo Z, Zou Q, Gu C, Xiang S, Li S, Ye Z, Wang S. Diagnosis accuracy of PCA3 level in patients with prostate cancer: a systematic review with meta-analysis. Int Braz J Urol. 2020 Sep-Oct;46(5):786-793. doi: 10.1590/S1677-5538.IBJU.2019.0521.
PubMed 32539255
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Upper Urinary Tract Stones by Shuotong Scope
- ClinicalTrials.gov ID
- NCT05712785
- Acronym / sponsor ID
- SFUUTS / 20231925-1
- Conditions
- Urinary Calculi, Ureterocele
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Handan First HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 3 Feb 2023 (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 purpose of this study is to use the Shuotong ureteroscopy for surgical treatment of patients with upper urinary tract stones, taking advantage of the fact that the Shuotong mirror can be used for simultaneous lithotripsy and stone removal, thus maximizing the discharge of stones from the body and improving the stone removal rate.
Detailed description
Ureteroscopy via the natural lumen has the advantages of being non-invasive, safe and repeatable. This is where Shuotongo ureteroscopy, a new type of ureteroscopy, has not yet become fully popular. Usually, most patients with upper urinary tract stones are treated by ureteroscopy or with flexible ureteroscopy, because these endoscopes usually break the stones and ask the patient to drink more water to expel the stones by themselves, after the operation, it is usually easy to leave stones in the body, and some patients even form stone streets to block the ureter again after the operation. In some patients, stones may form again and obstruct the ureter again. The Shuotong Ureteroscopy has the advantages of stone crushing and stone removal, which can synchronize the process of stone crushing and stone removal and maintain a good surgical view. It has the advantages of simple operation, less trauma and high safety for the operation via natural channel, especially for the large stones in the upper urinary tract and Gantun stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shuotong Ureteroscopy group | Experimental | Device: Use of shuotong ureteroscopyShuotong Ureteroscopy: a ureteroscope that can lithotripsy and lithotripsy simultaneously |
| Ureteroscopy group | No intervention | –Ureteroscopy group：using conventional ureteroscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Ureteral calculus Must be able to cooperate with the treatment
Key exclusion criteria (1 listed)
- Patients had severe urinary tract infections; patients had other conditions which investigators thought not suitable for the study.
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 |
|---|---|---|
| Use of shuotong ureteroscopyTreatment of patients with ureteral stones using the Shuotong-scopy | Device | Shuotong Ureteroscopy group |
Primary outcome
Stone removal rate
Time frame: 1 week after surgery
Residual stones in the body after surgery
1 secondary outcome
Surgery time
Time frame: During surgery
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 16 Mar 2023.
- Results publication: PubMed 34646858Lai L, Zhang W, Zheng F, Wang T, Bai P, Liu Z, Zheng J, Shao Z, Duan B, Wang H, Xing J, Chen H, Huang Y, Chen B. Comparison of the Efficacy of ShuoTong Ureteroscopy and Simple Flexible Ureteroscopy in the Treatment of Unilateral Upper Ureteral Calculi. Front Surg. 2021 Sep 27;8:707022. doi: 10.3389/fsurg.2021.707022. eCollection 2021.
- Results publication: PubMed 35818238Qiao D, Cheng L, Xiaomei T, Baolei S, Yingyi L, Hui Z, Shaohua B, Wei L, U DY, Fangqiong D, Jie L, Shuangning L. Effect of ultra-mini percutaneous nephrolithotomy and ShuoTong ureteroscopy on the stress response, inflammatory indices, and urokinase level in patients with polycystic kidney disease complicated with renal calculus. Cell Mol Biol (Noisy-le-grand). 2022 Feb 4;67(5):309-316. doi: 10.14715/cmb/2021.67.5.42.
- Results publication: PubMed 32539255Gan S, Guo Z, Zou Q, Gu C, Xiang S, Li S, Ye Z, Wang S. Diagnosis accuracy of PCA3 level in patients with prostate cancer: a systematic review with meta-analysis. Int Braz J Urol. 2020 Sep-Oct;46(5):786-793. doi: 10.1590/S1677-5538.IBJU.2019.0521.
- Individual participant dataSharing planned: No
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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.
kunwu yan, Master principal investigator
Handan First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of shuotong ureteroscopy in people with Urinary Calculi and Ureterocele, run by Handan First 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 1 inclusion and 1 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 16 Mar 2023. 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 kunwu yan, Master (+8618232053937, 1749200794@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone removal rate (time frame: 1 week after surgery). 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 NCT05712785, which also lists 3 linked publications.
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 16 Mar 2023; AzTrials last refreshed its copy on 2 Nov 2026.