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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05712785
Other study ID # 20231925-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date December 20, 2026

Study information

Verified date March 2023
Source Handan First Hospital
Contact kunwu yan, Master
Phone +8618232053937
Email 1749200794@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 stone removal rate.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 20, 2026
Est. primary completion date December 20, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of Ureteral calculus Must be able to cooperate with the treatment Exclusion Criteria: - Patients had severe urinary tract infections; patients had other conditions which investigators thought not suitable for the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Use of shuotong ureteroscopy
Treatment of patients with ureteral stones using the Shuotong-scopy

Locations

Country Name City State
China Kunwu Yan Handan Hebei

Sponsors (1)

Lead Sponsor Collaborator
Handan First Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Gan 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. — View Citation

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. Fr — View Citation

Qiao 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Stone removal rate Residual stones in the body after surgery 1 week after surgery
Secondary Surgery time Time from start of surgery to end of surgery During surgery
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