Comparison of Images of the Same Area in the Bladder in Four Different SPIES Modalities on a Tablet ComputerNCT02174302
Ì-SPIES, Comparison of Cystoscopy Images in Four Different SPIES Modalities
An observational study of Comparison of Images of the Same Area in the Bladder in Four Different SPIES Modalities on a Tablet Computer, run by Clinical Research Office of the Endourological Society.
Trial summary
Comparison of Images of the same area in the bladder in four different SPIES modalities on a tablet computer. Participants are asked to delineate the area on the image suspect for malignancy as precise as possible with a stylus on the tablet screen. Delineated area(s) is/are captured. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Comparison of Images of the Same Area in the Bladder in Four Different SPIES Modalities on a Tablet Computer
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 2014
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: urologists and resident urologist
Who may be able to join
- urologist or resident urologist
Who cannot join
- none
About this study
Comparison of Images of the same area in the bladder in four different SPIES modalities on a tablet computer. Participants are asked to delineate the area on the image suspect for malignancy as precise as possible with a stylus on the tablet screen. Delineated area(s) is/are captured. Time to start the drawing and total time per image are captured. Hereafter, an judgement of Image quality is asked on a scale of 0 to 10, 0 being worst possible and 10 being best possible.
Read the detailed description
Karl Storz Company has recently introduced the Storz Professional Image Enhancement System. To evaluate the interpretation of cystoscopy images in different SPIES modalities a tablet program was developed. Images of 20 bladder areas were captured in 4 different SPIES modalities; white light, Clara\&Chroma, Spectra A and Spectra B. Of each bladder area, one extra image was added to the program, so that a total of 100 images were interpreted.
Every image is shown 45 seconds on the tablet screen. Participants are asked to delineate with a stylus on the tablet the precise area they suspect to be malignant and would resect or treat. After they are done they go to the next slide and the time is stopped.After each image, participants are asked to judge the quality of the image on a scale of zero to ten, with zero being the worst and ten the best.After this judgement, the next image for interpretation is presented.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra observer variability in delineated areas between the same bladder areas in different SPIES modalities.
Measured: 1 hour
Inter observer variability in delineated areas between the same bladder areas in different SPIES modalities.
Measured: 1 hour
Image quality of images in different SPIES modalities
Measured: 1 hour
Secondary outcomes (6)
Differences in time to start delineation between images in different SPIES modalities
Measured: 1 hour
Differences in time needed per image in different SPIES modalities
Measured: 1 hour
Differences in use of úndo' button between different SPIES modalities
Measured: 1 hour
Differences in participants who are familiar with image enhancement system (NBI/SPIES) vs participants who are not familiar working with them.
Measured: 1 hour
Differences in interpretation of images between participants with a visual impairment or colourblindness vs participants without.
Measured: 1 hour
Differences in interpretations between participants in age or experience in TURBT annually.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of Images of the Same Area in the Bladder in Four Different SPIES Modalities on a Tablet ComputerStudies 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
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Office of the Endourological Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174302
- Sponsor's protocol ID
- 2014-6
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 2014
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ì-SPIES, Comparison of Cystoscopy Images in Four Different SPIES Modalities
- ClinicalTrials.gov ID
- NCT02174302
- Acronym / sponsor ID
- 2014-6
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Clinical Research Office of the Endourological SocietyUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Jun 2014 (estimated)
- 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.
Comparison of Images of the same area in the bladder in four different SPIES modalities on a tablet computer. Participants are asked to delineate the area on the image suspect for malignancy as precise as possible with a stylus on the tablet screen. Delineated area(s) is/are captured. Time to start the drawing and total time per image are captured. Hereafter, an judgement of Image quality is asked on a scale of 0 to 10, 0 being worst possible and 10 being best possible.
Detailed description
Karl Storz Company has recently introduced the Storz Professional Image Enhancement System. To evaluate the interpretation of cystoscopy images in different SPIES modalities a tablet program was developed. Images of 20 bladder areas were captured in 4 different SPIES modalities; white light, Clara\&Chroma, Spectra A and Spectra B. Of each bladder area, one extra image was added to the program, so that a total of 100 images were interpreted.
Every image is shown 45 seconds on the tablet screen. Participants are asked to delineate with a stylus on the tablet the precise area they suspect to be malignant and would resect or treat. After they are done they go to the next slide and the time is stopped.After each image, participants are asked to judge the quality of the image on a scale of zero to ten, with zero being the worst and ten the best.After this judgement, the next image for interpretation is presented.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- urologists and resident urologist
Key inclusion criteria (1 listed)
- urologist or resident urologist
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.
Primary outcome
Intra observer variability in delineated areas between the same bladder areas in different SPIES modalities.
Time frame: 1 hour
Inter observer variability in delineated areas between the same bladder areas in different SPIES modalities.
Time frame: 1 hour
Image quality of images in different SPIES modalities
Time frame: 1 hour
6 secondary outcomes
Differences in time to start delineation between images in different SPIES modalities
Time frame: 1 hour
Differences in time needed per image in different SPIES modalities
Time frame: 1 hour
Differences in use of úndo' button between different SPIES modalities
Time frame: 1 hour
Differences in participants who are familiar with image enhancement system (NBI/SPIES) vs participants who are not familiar working with them.
Time frame: 1 hour
Differences in interpretation of images between participants with a visual impairment or colourblindness vs participants without.
Time frame: 1 hour
Differences in interpretations between participants in age or experience in TURBT annually.
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- Related InfoLink provided by the sponsor.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Comparison of Images of the Same Area in the Bladder in Four Different SPIES Modalities on a Tablet Computer, run by Clinical Research Office of the Endourological Society.
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: finished, as of the sponsor's last update on 25 Jun 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intra observer variability in delineated areas between the same bladder areas in different SPIES modalities. (time frame: 1 hour). The study lists 3 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 25 Jun 2014.