PyeloplastyNCT03939091
Ultrasonographic Versus Renographic Parameters in Prediction of Early Success After Pyeloplasty in Children
A study testing Ultrasonography in people with Pyeloplasty and Pediatrics, run by Mansoura University at 1 site in Egypt.
Trial summary
To study the predictive value of ultrasonographic (USG) parameters in the form of anteroposterior diameter , calyceal dilatation , calyx-to-parenchyma ratio , renal length , renal width , pelvis-to-cortex ratio (PCR) and parenchymal thickness versus renographic parameters in the form of T1/2 , differential renal… Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Pyeloplasty, Pediatrics, Renogram
- What is being tested?
- Ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Jun 2020
- Phase
- Interventional
- 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 6 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients who will be scedueled for pyeloplasty
Who cannot join
- bilateral pathology
- Pelvi-ureteric junction obstruction (PUJO) in a solitary kidney
- other associated anomalies
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and nephrology center
Al Mansurah, Outside U.S./Canada, 35516
Ahmed Shoma, 502202222, ahmed.shoma@hotmail.com
About this study
Official title: Ultrasonographic Versus Renographic Parameters in Prediction of Early Success After Pyeloplasty in Children. A Prospective Study.
To study the predictive value of ultrasonographic (USG) parameters in the form of anteroposterior diameter , calyceal dilatation , calyx-to-parenchyma ratio , renal length , renal width , pelvis-to-cortex ratio (PCR) and parenchymal thickness versus renographic parameters in the form of T1/2 , differential renal function (DRF) and Tissue tracer transit (TTT) for early detection of children at risk of recurrent obstruction post unilateral pyeloplasty.
- Conditions
- Pyeloplasty, Pediatrics, Renogram, Ultrasonography
- Being tested
- Ultrasonography
- Keywords
- Ultrasonography, Pyeloplasty, Renogram, Follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
Renal Ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonography | Other | Renal Ultrasonography Receives: Diagnostic Test: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate predictive value of ultrasonographic parameters for early detection of recurrent obstruction
assessed by Diuretic scintigraphy (T1/2) as the time it takes for the activity in the kidney to decrease to 50% of its maximum value measured in minutes
Measured: 30 months
evaluate predictive value of ultrasonographic parameters for early detection of decrease renal function
assessed by Diuretic scintigraphy differential renal function (DRF) measured in millilitres/minute
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jan 2018
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyeloplastyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelazeem, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939091
- Sponsor's protocol ID
- Renogram.US.Pyeloplasty
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Versus Renographic Parameters in Prediction of Early Success After Pyeloplasty in Children. A Prospective Study.
- ClinicalTrials.gov ID
- NCT03939091
- Acronym / sponsor ID
- Renogram.US.Pyeloplasty
- Conditions
- Pyeloplasty, Pediatrics, Renogram, Ultrasonography
- Keywords
- Ultrasonography, Pyeloplasty, Renogram, Follow up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 6 May 2019 (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.
To study the predictive value of ultrasonographic (USG) parameters in the form of anteroposterior diameter , calyceal dilatation , calyx-to-parenchyma ratio , renal length , renal width , pelvis-to-cortex ratio (PCR) and parenchymal thickness versus renographic parameters in the form of T1/2 , differential renal function (DRF) and Tissue tracer transit (TTT) for early detection of children at risk of recurrent obstruction post unilateral pyeloplasty.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasonography | Other | Diagnostic Test: UltrasonographyRenal Ultrasonography |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients who will be scedueled for pyeloplasty
Key exclusion criteria (3 listed)
- bilateral pathology
- Pelvi-ureteric junction obstruction (PUJO) in a solitary kidney
- other associated anomalies
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 |
|---|---|---|
| UltrasonographyRenal Ultrasonography | Diagnostic test | Ultrasonography |
Primary outcome
evaluate predictive value of ultrasonographic parameters for early detection of recurrent obstruction
Time frame: 30 months
assessed by Diuretic scintigraphy (T1/2) as the time it takes for the activity in the kidney to decrease to 50% of its maximum value measured in minutes
evaluate predictive value of ultrasonographic parameters for early detection of decrease renal function
Time frame: 30 months
assessed by Diuretic scintigraphy differential renal function (DRF) measured in millilitres/minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography in people with Pyeloplasty and Pediatrics, run by Mansoura University at 1 site in Egypt.
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 3 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 6 May 2019. 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate predictive value of ultrasonographic parameters for early detection of recurrent obstruction (time frame: 30 months). The study lists 2 primary outcomes in all. 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 6 May 2019.