Narrow Band Imaging in Flexible Cystoscopy Clinical Trial
— DaBlaCa-7Official title:
Narrow Band Imaging in Flexible Cystocopy - DaBlaCa-7
| NCT number | NCT02313636 |
| Other study ID # | DaBlaCa-7 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2014 |
| Est. completion date | November 2015 |
| Verified date | May 2023 |
| Source | Aarhus University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 955 |
| Est. completion date | November 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC Exclusion Criteria: - Patients not fullfilling the above |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aarhus University Hospital | Århus N | |
| Denmark | Herlev Hospital | Herlev | |
| Denmark | Hospitalsenheden Vest | Holstebro |
| Lead Sponsor | Collaborator |
|---|---|
| Aarhus University Hospital | Herlev Hospital, Hospitalsenheden Vest, Oslo University Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in the clinical decision | Baseline |