Ureteral Stent-Related SymptomNCT05495659
Detection of Ureteral Stent Encrustation
An observational study of Ureteral Stent-Related Symptom, run by Fifth Affiliated Hospital, Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Ureteral Stent-Related Symptom
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: People aged 12-80 who are scheduled to undergo ureteral stent placement due to urinary calculi, obstruction, etc.; and the estimated time for ureteral stent placement is greater than 2 weeks but less than 1 year.
Who may be able to join
- Patients who plan to undergo ureteral stent placement due to urinary calculi or urinary system obstruction;
- Aged over 12 years old;
- The estimated time of ureteral stent placement is more than 2 weeks but less than 1 year;
- Voluntarily participate in this clinical study, abide by the requirements of this clinical study and sign the informed consent.
Who cannot join
- Transplanted kidney, severe urinary system deformity, hydronephrosis caused by the compression of tumors of the urinary system and surrounding organs (such as cervical cancer);
- There are serious diseases in heart, lung, liver and other major organs;
- Pregnancy;
- The subject cannot complete the study or comply with the requirements of the study (due to administrative reasons or other reasons).
About this study
Official title: Clinical Study of GREE(a Name of Chinese Company)-AI(Artificial Intelligence) Medical Software in the Detection of Ureteral Stent Encrustation
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
- Keywords
- GREE-AI medical software, ureteral stent, encrustation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with ureteral stent encrustation longer than 4mm measured by a ruler
After indwelling the ureteral stent, ureteral stent encrustation will be formed, which affects the patency of the ureter or causes difficulty in extubation. Our observation outcome is to observe whether the ureteral stent encrustation formed.
Measured: When the patient returns to the hospital to remove the ureteral stent, it may be 2 weeks to 1 year after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral Stent-Related SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minbo Yan, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495659
- Sponsor's protocol ID
- FSYS-2022-K122-1
- Status last verified
- Aug 2022
- First submitted
- 31 Jul 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of GREE(a Name of Chinese Company)-AI(Artificial Intelligence) Medical Software in the Detection of Ureteral Stent Encrustation
- ClinicalTrials.gov ID
- NCT05495659
- Acronym / sponsor ID
- FSYS-2022-K122-1
- Conditions
- Ureteral Stent-Related Symptom
- Keywords
- GREE-AI medical software, ureteral stent, encrustation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- People aged 12-80 who are scheduled to undergo ureteral stent placement due to urinary calculi, obstruction, etc.; and the estimated time for ureteral stent placement is greater than 2 weeks but less than 1 year.
Key inclusion criteria (4 listed)
- Patients who plan to undergo ureteral stent placement due to urinary calculi or urinary system obstruction;
- Aged over 12 years old;
- The estimated time of ureteral stent placement is more than 2 weeks but less than 1 year;
- Voluntarily participate in this clinical study, abide by the requirements of this clinical study and sign the informed consent.
Key exclusion criteria (4 listed)
- Transplanted kidney, severe urinary system deformity, hydronephrosis caused by the compression of tumors of the urinary system and surrounding organs (such as cervical cancer);
- There are serious diseases in heart, lung, liver and other major organs;
- Pregnancy;
- The subject cannot complete the study or comply with the requirements of the study (due to administrative reasons or other reasons).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with ureteral stent encrustation longer than 4mm measured by a ruler
Time frame: When the patient returns to the hospital to remove the ureteral stent, it may be 2 weeks to 1 year after the operation.
After indwelling the ureteral stent, ureteral stent encrustation will be formed, which affects the patency of the ureter or causes difficulty in extubation. Our observation outcome is to observe whether the ureteral stent encrustation formed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteral Stent-Related Symptom, run by Fifth Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with ureteral stent encrustation longer than 4mm measured by a ruler (time frame: When the patient returns to the hospital to remove the ureteral stent, it may be 2 weeks to 1 year after the operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.