Plain English Summary
Background and study aims
Kidney stones are stone-like lumps that can develop in one or both of the kidneys. We are carrying out a study of 30 patients presenting in the emergency department for kidney stones. We want to find out whether a technique of X-ray scanning requiring only about one-third of the radiation dose used for normal X-ray, called LODOX, can detect kidney stones. Our goal is to eventually reduce the radiation dosage needed for kidney stone detection and follow-up.
Who can participate?
Adults over 18, presenting in our emergency department for kidney stones.
What does the study involve?
Patients receive a LODOX-Statscan in our emergency department after the existence of kidney stones has been proved by computed tomography (CT) scan.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part, but if our study shows that kidney stones really can be found by LODOX-Statscan, in future a LODOX could replace the conventional radiography. This means that future patients will benefit from the lower radiation dosage of the LODOX. Radiation dosage is an issue because radiation is known for its potential of causing cancer. The main risk is the additional radiation dose of the LODOX. However, the dose is very small.
Where is the study run from?
The study has been set up by the Urology Department of the University of Bern (Switzerland).
When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in November 2014. Participants will be enrolled on the study for a period of six months.
Who is funding the study?
University Clinic of Urology (Urologische Universitaetsklinik) (Switzerland).
Who is the main contact?
Dr Stefanie Hnilicka
urology.berne@insel.ch
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A pilot study to evaluate if low-dosage, digital X-ray scanning (LODOX-Statscan) can detect ureteral stones
Acronym
N/A
Study hypothesis
It is hypothesised that ureteral stones are visible in low-dosage, digital X-ray scanning (LODOX-Statscan) and that stone detection with LODOX is superior compared to conventional radiography while requiring lower radiation dosage.
Ethics approval
Ethical Committee of the Canton Bern, Switzerland, 11/2013, ref: 156/12
Study design
Pilot study
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Kidney and ureteral stones/reducing radiation dosage
Intervention
CT scan in all patients. A low-dosage, digital X-ray scanning (LODOX-Statscan) requiring a radiation dose of about 80 µSv will be performed in all participants. Total duration of intervention: approximately 5 minutes.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Stone detection rate by LODOX
Secondary outcome measures
1. Reducing radiation dosage
2. Comparability of stone size measured in LODOX, CT and conventional radiography
3. Fine-tuning adjustment of LODOX
Overall trial start date
20/11/2014
Overall trial end date
20/05/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with kidney or ureteral stones proved by computed tomography (CT)
2. > 18 years
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Total final enrolment
41
Participant exclusion criteria
1. Persistent, analgetic resistant pain
2. Pregnancy
Recruitment start date
20/11/2014
Recruitment end date
20/05/2015
Locations
Countries of recruitment
Switzerland
Trial participating centre
Anna-Seiler-Haus
Bern
3010
Switzerland
Funders
Funder type
University/education
Funder name
University Clinic of Urology (Urologische Universitaetsklinik) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31165230 (added 06/06/2019)