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The role of Image Enhancement Systems in the management of patients with non-muscle invasive bladder cancer

White light imaging vs. Storz Professional Image Enhancement System (SPIES) cystoscopy during follow up of patients submitted to White light – transurethral resection of non-muscle-invasive bladder cancer: A randomized diagnostic trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN90207346
Enrollment
211
Registered
2016-11-03
Start date
2015-02-20
Completion date
Unknown
Last updated
2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-muscle-invasive bladder cancer (NMIBC) Cancer

Interventions

All patients with suspected or confirmed NMIBC submitted to (TUR-NMIBC) using WLI (WLI-TUR-NMIBC) fulfilling specific inclusion criteria will be consecutively and prospectively recruited in the study.
Karl Storz, Tuttlingen, Germany)).

Sponsors

University of Crete, Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with suspected or confirmed NMIBC fulfilling the following inclusion criteria will be prospectively recruited in the study: 1. Prior WLI-TUR-NMIBC of primary or recurrent tumor(s) 2. Age =18 years 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Participation in a similar protocol 2. Absence of upper urinary tract tumors 3. Pregnancy/breastfeeding

Design outcomes

Primary

MeasureTime frame
Recurrence rate detection of both the reference and index tests, using positive values for tumour recurrence and negative values for no tumour reoccurrence at 3, 9, 12, 18 and 24 months after WLI-TUR-NMIBC.

Secondary

MeasureTime frame
To evaluate the contribution of each cystoscopy type (WLI vs SPIES) in the diagnosis of NMIBC in patients with positive urine cytology, via comparison of diagnosis rates between the two tests

Countries

Greece

Contacts

Public ContactCharalampos Mamoulakis
mamoulak@uoc.gr+30 2810 392340

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026