Obstructive UropathyNCT04605835
Ultrasonic Visualization of Obstructive Uropathies in Children
An observational study of Obstructive Uropathy, run by Samarkand State Medical Institute at 1 site in Uzbekistan.
Trial summary
The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Obstructive Uropathy
- What is being tested?
- ULTRASONIC VISUALIZATION OF OBSTRUCTIVE UROPATHIES IN CHILDREN.
- How many people
- 655 participants
- Where
- 1 siteUzbekistan
- Study dates
- 2 Mar 2018to 30 Jan 2025
- 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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 60 in children with obstructive uropathies (30 children with congenital hydronephrosis and 30 children with congenital ureterohydronephrosis).
Who may be able to join
- 655 children with congenital obstruction of the upper urinary tract
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonic Visualization of Renal Function Damage and Urodynamic Disorders for Obstructive Uropathies in Children
The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.
Read the detailed description
Relevance. The prevalence of congenital diseases of the genitourinary system is 0.5-7.5 per 1000 newborns; The high prevalence reflects the medical and social significance of the problem and determines the need to search for highly informative and safe diagnostic methods for the child's body, providing timely treatment, restoration of the somatic and social status of children.
Purpose. Development of proposals and recommendations to improve the safety of urological examination of children with obstructive uropathy.
Material and methods. The study is based on the analysis of the results of diagnosis and treatment of 655 children with congenital obstruction of the upper urinary tract. The complex of urological examination included clinical, laboratory, morphological, radiological, ultrasound research methods.
- Conditions
- Obstructive Uropathy
- Being tested
- ULTRASONIC VISUALIZATION OF OBSTRUCTIVE UROPATHIES IN CHILDREN.
- Keywords
- obstructive uropathy, children, ultrasound, Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRASONIC VISUALIZATION OF OBSTRUCTIVE UROPATHIES IN CHILDREN.Diagnostic test
The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.
| Study group | Role | What they receive |
|---|---|---|
| Main group | 484 children with congenital obstructive uropathies Receives: Diagnostic Test: ULTRASONIC VISUALIZATION OF OBSTRUCTIVE UROPATHIES IN CHILDREN. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonic visualization of renal function damage and urodynamic disorders for obstructive uropathies in children.
The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start2 Mar 2018
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive UropathyStudies 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
- Retrospective
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samarkand State Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605835
- Sponsor's protocol ID
- DGU 20200967
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Visualization of Renal Function Damage and Urodynamic Disorders for Obstructive Uropathies in Children
- ClinicalTrials.gov ID
- NCT04605835
- Acronym / sponsor ID
- DGU 20200967
- Conditions
- Obstructive Uropathy
- Keywords
- obstructive uropathy, children, ultrasound, Doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 655 participants (actual)
- Lead sponsor
- Samarkand State Medical InstituteUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 28 Oct 2020 (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.
The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.
Detailed description
Relevance. The prevalence of congenital diseases of the genitourinary system is 0.5-7.5 per 1000 newborns; The high prevalence reflects the medical and social significance of the problem and determines the need to search for highly informative and safe diagnostic methods for the child's body, providing timely treatment, restoration of the somatic and social status of children.
Purpose. Development of proposals and recommendations to improve the safety of urological examination of children with obstructive uropathy.
Material and methods. The study is based on the analysis of the results of diagnosis and treatment of 655 children with congenital obstruction of the upper urinary tract. The complex of urological examination included clinical, laboratory, morphological, radiological, ultrasound research methods.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main group | – | Diagnostic Test: ULTRASONIC VISUALIZATION OF OBSTRUCTIVE UROPATHIES IN CHILDREN.484 children with congenital obstructive uropathies |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 60 in children with obstructive uropathies (30 children with congenital hydronephrosis and 30 children with congenital ureterohydronephrosis).
Key inclusion criteria (1 listed)
- 655 children with congenital obstruction of the upper urinary tract
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ULTRASONIC VISUALIZATION OF OBSTRUCTIVE UROPATHIES IN CHILDREN.The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy. | Diagnostic test | Main group |
Primary outcome
Ultrasonic visualization of renal function damage and urodynamic disorders for obstructive uropathies in children.
Time frame: up to 36 months
The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- American Journal of RoentgenologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Obstructive Uropathy
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Safety and Efficacy of Ultrasound-Guided Percutaneous Nephrostomy in Oncology Patients
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Recruiting
Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria
Calculous Anuria, Upper Ureteral Stone
RecruitingPhase 2
Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous Anuria
Acute Calculous Anuria, Ureteral Calculi
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Uropathy, run by Samarkand State Medical Institute at 1 site in Uzbekistan.
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 1 inclusion and 1 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 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Ultrasonic visualization of renal function damage and urodynamic disorders for obstructive uropathies in children. (time frame: up to 36 months). 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 28 Oct 2020; AzTrials last refreshed its copy on 3 Nov 2026.