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RecruitingNCT05712785SFUUTSUpdated Mar 16, 2023

Shuotongo Ureteroscopy for Upper Urinary Tract Stones

An interventional study of Use of shuotong ureteroscopy in Urinary Calculi and Ureterocele, sponsored by Handan First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-16.

Sponsored by Handan First Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Jan 2020, registered Jan 2023).
  • Started Jan 2020; still recruiting 6 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Urinary Calculi
  • Ureterocele

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03

In context

Urinary Calculi

94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.

This study's planned enrollment of 200 is above the median of 120 across 61 interventional studies indexed under Urinary Calculi.

Browse Urinary Calculi studies →

Lead sponsor

Handan First Hospital is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of Ureteral calculus Must be able to cooperate with the treatment

Exclusion criteria

Exclusion Criteria:

  • Patients had severe urinary tract infections; patients had other conditions which investigators thought not suitable for the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Shuotong Ureteroscopy group

    Shuotong Ureteroscopy: a ureteroscope that can lithotripsy and lithotripsy simultaneously

    Device: Use of shuotong ureteroscopy

  • No intervention
    Ureteroscopy group

    Ureteroscopy group:using conventional ureteroscopy

Interventions

  • DeviceUse of shuotong ureteroscopy

    Treatment of patients with ureteral stones using the Shuotong-scopy

06

What researchers measure

Primary outcomes

  1. Stone removal rate

    Residual stones in the body after surgery

    Time frame: 1 week after surgery

Secondary outcomes

  1. Surgery time

    Time from start of surgery to end of surgery

    Time frame: During surgery

07

Study locations

1 of 1 sites recruiting
  • Kunwu Yan
    Handan, Hebei 056000, China
    Recruiting
08

References and documents

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 34646858 ↗
  • 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. PubMed 35818238 ↗
  • 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. PubMed 32539255 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05712785
Lead sponsor
Handan First Hospital
Responsible party
kunwu-yan (Research Project Leader, Handan First Hospital) — Principal investigator
First posted
Feb 3, 2023
Start date
Jan 1, 2020
Primary completion
Dec 20, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Mar 16, 2023

Study contacts

kunwu yan, Master
Contact
1749200794@qq.com
+8618232053937
xiaofei tian, Master
Contact
fei19860703@126.com
+8603108635584
kunwu yan, Master
principal investigator · Handan First Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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