NCT05712785

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2020Dec 2026

Study Start

First participant enrolled

January 1, 2020

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

7 years

First QC Date

January 26, 2023

Last Update Submit

March 14, 2023

Conditions

Urinary CalculiUreterocele

Outcome Measures

Primary Outcomes (1)

  • Stone removal rate

    Residual stones in the body after surgery

    1 week after surgery

Secondary Outcomes (1)

  • Surgery time

    During surgery

Study Arms (2)

Shuotong Ureteroscopy group

EXPERIMENTAL

Shuotong Ureteroscopy: a ureteroscope that can lithotripsy and lithotripsy simultaneously

Device: Use of shuotong ureteroscopy

Ureteroscopy group

NO INTERVENTION

Ureteroscopy group：using conventional ureteroscopy

Interventions

Use of shuotong ureteroscopyDEVICE

Treatment of patients with ureteral stones using the Shuotong-scopy

Shuotong Ureteroscopy group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kunwu Yan

Handan, Hebei, 056000, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 34646858RESULT

  • 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.

    PMID: 35818238RESULT

  • 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.

    PMID: 32539255RESULT

MeSH Terms

Conditions

Urinary CalculiUreterocele

Condition Hierarchy (Ancestors)

UrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUreteral Diseases

Study Officials

  • kunwu yan, Master

    Handan First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kunwu yan, Master

CONTACT

+86182320539371749200794@qq.com

xiaofei tian, Master

CONTACT

+8603108635584fei19860703@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Project Leader

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 3, 2023

Study Start

January 1, 2020

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)