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Detection of Ureteral Stent Encrustation

NCT05495659 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 156

Last updated 2022-08-10

No results posted yet for this study

Summary

Ureteral stents are the most commonly used postoperative implantable materials in urology. The indwelling ureteral stents often lead to the formation of encrustation, with an incidence of 10%, which will lead to complications such as obstruction, lower urinary tract symptom (LUTS）, and difficulty in extubation. At present, there is no accurate and sensitive diagnostic criteria for ureteral stents encrustation. Previously, we developed the artificial intelligence-based ureteral stents encrustation identification software - GREE-AI Medical Software (GAIMS) with the collaboration of GREE ELECTRIC APPLIANCES,INCORPORATED.OF ZHUHAI(a city of Guangdong, China). In order to further evaluate the diagnostic sensitivity and accuracy of the software in practical clinical applications, and to verify its predictive ability for ureteral stents encrustation, the following single-center, prospective, double-blind, diagnostic cohort study is planned.

This study will use the gold standard as a reference to evaluate the sensitivity and specificity of GAIMS for detecting ureteral stents encrustation. At the same time, it will be compared with non-enhanced contrast Computed Tomography examinations interpreted by clinical radiologists to evaluate the pros and cons of GAIMS in detecting ureteral stents encrustation.

Conditions

  • Ureteral Stent-Related Symptom

Sponsors & Collaborators

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2024-08-01
Completion
2024-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05495659 on ClinicalTrials.gov