Narrow Band Imaging in Flexible CystoscopyDaBlaCa-7NCT02313636
Narrow Band Imaging in Flexible Cystocopy
An observational study of Narrow Band Imaging in Flexible Cystoscopy, run by Aarhus University Hospital at 3 sites in Denmark.
Trial summary
Patients with first time hematuria or patients previously diagnosed with papillomas/CIS of the bladder are included in the study. All surgeons are highly experienced in WL cystoscopy and familiar with NBI findings. Cystoscopy is performed with HD cameras and Olympus light sources. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narrow Band Imaging in Flexible Cystoscopy
- How many people
- 955 participants
- Where
- 3 sitesDenmark
- Study dates
- May 2014to Nov 2015
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC
Who may be able to join
- Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC
Who cannot join
- Patients not fullfilling the above
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hospital
Århus N, 8200
Herlev Hospital
Herlev
Hospitalsenheden Vest
Holstebro
About this study
Official title: Narrow Band Imaging in Flexible Cystocopy - DaBlaCa-7
Patients with first time hematuria or patients previously diagnosed with papillomas/CIS of the bladder are included in the study. All surgeons are highly experienced in WL cystoscopy and familiar with NBI findings. Cystoscopy is performed with HD cameras and Olympus light sources.
First, a systematic cystoscopy is made in WL. Secondly, the clinical decision is noted. After WL, the cystoscopy is made with NBI and any potential subsequent change in the clinical decision is noted.
A total number of 896 patients is planned to be included.
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the clinical decision
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narrow Band Imaging in Flexible CystoscopyStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 955 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Hospitalsenheden Vest, Oslo University Hospital
- Responsible party
- Principal investigator, Jørgen Bjerggaard Jensen, Aarhus University Hospital
- Investigators
- Jørgen Bjerggaard Jensen, DMSc, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313636
- Sponsor's protocol ID
- DaBlaCa-7
- Acronym
- DaBlaCa-7
- Status last verified
- May 2023
- First submitted
- 8 Dec 2014
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow Band Imaging in Flexible Cystocopy - DaBlaCa-7
- ClinicalTrials.gov ID
- NCT02313636
- Acronym / sponsor ID
- DaBlaCa-7 / DaBlaCa-7
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 955 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Herlev Hospital, Hospitalsenheden Vest, Oslo University Hospital
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Dec 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.
Patients with first time hematuria or patients previously diagnosed with papillomas/CIS of the bladder are included in the study. All surgeons are highly experienced in WL cystoscopy and familiar with NBI findings. Cystoscopy is performed with HD cameras and Olympus light sources.
First, a systematic cystoscopy is made in WL. Secondly, the clinical decision is noted. After WL, the cystoscopy is made with NBI and any potential subsequent change in the clinical decision is noted.
A total number of 896 patients is planned to be included.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC
Key inclusion criteria (1 listed)
- Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC
Key exclusion criteria (1 listed)
- Patients not fullfilling the above
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
change in the clinical decision
Time frame: Baseline
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 31 May 2023.
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.
Jørgen Bjerggaard Jensen, DMSc principal investigator
University of Aarhus
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narrow Band Imaging in Flexible Cystoscopy, run by Aarhus University Hospital at 3 sites in Denmark.
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 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
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?
change in the clinical decision (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 31 May 2023.