Shuotongo Ureteroscopy for Upper Urinary Tract Stones (SFUUTS)
Primary Purpose
Urinary Calculi, Ureterocele
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Use of shuotong ureteroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Calculi
Eligibility Criteria
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.
Sites / Locations
- Kunwu YanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Shuotong Ureteroscopy group
Ureteroscopy group
Arm Description
Shuotong Ureteroscopy: a ureteroscope that can lithotripsy and lithotripsy simultaneously
Ureteroscopy group:using conventional ureteroscopy
Outcomes
Primary Outcome Measures
Stone removal rate
Residual stones in the body after surgery
Secondary Outcome Measures
Surgery time
Time from start of surgery to end of surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05712785
Brief Title
Shuotongo Ureteroscopy for Upper Urinary Tract Stones
Acronym
SFUUTS
Official Title
Clinical Study on the Treatment of Upper Urinary Tract Stones by Shuotong Scope
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 20, 2026 (Anticipated)
Study Completion Date
December 20, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Handan First Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Calculi, Ureterocele
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shuotong Ureteroscopy group
Arm Type
Experimental
Arm Description
Shuotong Ureteroscopy: a ureteroscope that can lithotripsy and lithotripsy simultaneously
Arm Title
Ureteroscopy group
Arm Type
No Intervention
Arm Description
Ureteroscopy group:using conventional ureteroscopy
Intervention Type
Device
Intervention Name(s)
Use of shuotong ureteroscopy
Intervention Description
Treatment of patients with ureteral stones using the Shuotong-scopy
Primary Outcome Measure Information:
Title
Stone removal rate
Description
Residual stones in the body after surgery
Time Frame
1 week after surgery
Secondary Outcome Measure Information:
Title
Surgery time
Description
Time from start of surgery to end of surgery
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kunwu yan, Master
Phone
+8618232053937
Email
1749200794@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
xiaofei tian, Master
Phone
+8603108635584
Email
fei19860703@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kunwu yan, Master
Organizational Affiliation
Handan First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kunwu Yan
City
Handan
State/Province
Hebei
ZIP/Postal Code
056000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
kunwu yan, Master
Phone
+8618232053937
Email
1749200794@qq.com
First Name & Middle Initial & Last Name & Degree
xiaofei tian, Master
Phone
+8615233882780
Email
fei19860703@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34646858
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. Front Surg. 2021 Sep 27;8:707022. doi: 10.3389/fsurg.2021.707022. eCollection 2021.
Results Reference
result
PubMed Identifier
35818238
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 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 Reference
result
PubMed Identifier
32539255
Citation
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.
Results Reference
result
Learn more about this trial
Shuotongo Ureteroscopy for Upper Urinary Tract Stones
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