Urinary CalculiNCT04110574
Computed Tomography Evaluation of Urinary Stones Densities Compared to in Vitro Analysis of Its Chemical Composition
An observational study of Urinary Calculi, run by Assiut University.
Trial summary
The ability to predict stone composition, which influences patient treatment, depends on the accurate measurement of CT attenuation of stones. We will study the effects of stone composition, stone size, and scan collimation width on the measurement of attenuation in vitro. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Calculi
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2020to 30 Oct 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with suspected or known urinary stone disease and were included in the study who attend to out patient clinic of Urology department of Assiut university hospital or admitted in the ward.
Who may be able to join
- Any Age will be included .
- Patient with suspected or known urinary stone disease.
- Eligible for doing NCCT.
- Giving written consent to participate
Who cannot join
- Patient with classical NCCT contraindication like morbid obesity and pregnancy .
- Patients with urinary stones will be treated by ESWL
- Refusal participation .
Trial locations and contacts
No sites are listed yet.
About this study
The ability to predict stone composition, which influences patient treatment, depends on the accurate measurement of CT attenuation of stones. We will study the effects of stone composition, stone size, and scan collimation width on the measurement of attenuation in vitro.
Read the detailed description
Recently, the use of noncontrast spiral computerized tomography (NCCT) has gained widespread acceptance in the evaluation of urinary stone patients. It has long been used clinically to evaluate the causes of radiolucent filling defects using Hounsfield units (HU) to distinguish calculi from tumor or blood clots, and to identify nonurologic causes of flank pain (Smith R etal ). Urinary stones have a significantly higher CT attenuation than the surrounding soft tissues and are virtually always visible on NCCT. Knowing the composition of a urinary calculus is frequently a key factor in determining its most appropriate management. Should the urine be alkalinized? Will the stone be amenable to extracorporeal shock wave lithotripsy (ESWL), or should ureteroscopy or percutaneous lithotripsy be attempted? Different techniques have been used to assist in determining the correct chemical composition of calculi. Urine pH, urinary crystals, prior stone history and the presence of urea-splitting organisms (Ramakumar S,etal). Several in vitro studies have suggested that NCCT can demonstrate measured differences in radiodensity among different urinary stones (Mitchenson HD etal,).With these clinical problems in mind, we sought to determine whether the composition of urinary calculi could be predicted by their CT characteristics in an attempt to find out the best technique for distinguishing the various stones compositions, provided that it is clinically practical and would not require repeated imaging of the patients.
- Conditions
- Urinary Calculi
- Medical subject headings
- Urinary Calculi
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of CT densities of urinary stones with its chemical composition
determination whether the composition of urinary calculi could be predicted by their CT characteristics in an attempt to find out the best technique for distinguishing the various stones compositions .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start30 Mar 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CalculiStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somia Usama Mohamed Rabea, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110574
- Sponsor's protocol ID
- CT of urinary stones densities
- Status last verified
- Feb 2020
- First submitted
- 28 Sep 2019
- Last updated
- 5 Feb 2020
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Evaluation of Urinary Stones Densities Compared to in Vitro Analysis of Its Chemical Composition
- ClinicalTrials.gov ID
- NCT04110574
- Acronym / sponsor ID
- CT of urinary stones densities
- Conditions
- Urinary Calculi
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 1 Oct 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.
The ability to predict stone composition, which influences patient treatment, depends on the accurate measurement of CT attenuation of stones. We will study the effects of stone composition, stone size, and scan collimation width on the measurement of attenuation in vitro.
Detailed description
Recently, the use of noncontrast spiral computerized tomography (NCCT) has gained widespread acceptance in the evaluation of urinary stone patients. It has long been used clinically to evaluate the causes of radiolucent filling defects using Hounsfield units (HU) to distinguish calculi from tumor or blood clots, and to identify nonurologic causes of flank pain (Smith R etal ). Urinary stones have a significantly higher CT attenuation than the surrounding soft tissues and are virtually always visible on NCCT. Knowing the composition of a urinary calculus is frequently a key factor in determining its most appropriate management. Should the urine be alkalinized? Will the stone be amenable to extracorporeal shock wave lithotripsy (ESWL), or should ureteroscopy or percutaneous lithotripsy be attempted? Different techniques have been used to assist in determining the correct chemical composition of calculi. Urine pH, urinary crystals, prior stone history and the presence of urea-splitting organisms (Ramakumar S,etal). Several in vitro studies have suggested that NCCT can demonstrate measured differences in radiodensity among different urinary stones (Mitchenson HD etal,).With these clinical problems in mind, we sought to determine whether the composition of urinary calculi could be predicted by their CT characteristics in an attempt to find out the best technique for distinguishing the various stones compositions, provided that it is clinically practical and would not require repeated imaging of the patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected or known urinary stone disease and were included in the study who attend to out patient clinic of Urology department of Assiut university hospital or admitted in the ward.
Key inclusion criteria (4 listed)
- Any Age will be included .
- Patient with suspected or known urinary stone disease.
- Eligible for doing NCCT.
- Giving written consent to participate
Key exclusion criteria (3 listed)
- Patient with classical NCCT contraindication like morbid obesity and pregnancy .
- Patients with urinary stones will be treated by ESWL
- Refusal participation .
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
comparison of CT densities of urinary stones with its chemical composition
Time frame: Baseline
determination whether the composition of urinary calculi could be predicted by their CT characteristics in an attempt to find out the best technique for distinguishing the various stones compositions .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Determination of the chemical composition of urinary calculi by non contrast spiral computerized tomography.Link provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Calculi, run by Assiut 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 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 5 Feb 2020. 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?
Contact Somia Usama, Master (01060101215, somiaumrm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of CT densities of urinary stones with its chemical composition (time frame: Baseline). 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 5 Feb 2020.