Condition category
Urological and Genital Diseases
Date applied
13/11/2014
Date assigned
10/12/2014
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Stefanie Hnilicka

ORCID ID

Contact details

Anna-Seiler-Haus
Inselspital
Bern
3010
Switzerland

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

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

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

Sponsor information

Organisation

University Clinic of Urology (Urologische Universitaetsklinik) (Switzerland)

Sponsor details

c/o Dr Stefanie Hnilicka
Inselspital
Bern
3010
Switzerland

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes