HYbrid Knife in Bladder Cancer Resection Initially Detected by Hexvix based BLUe-Light Enhancement

HYbrid Knife in Bladder Cancer Resection Initially Detected by Hexvix based BLUe-Light Enhancement - HybridBlue

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004414

Enrollment

120

Registered

2012-11-07

Start date

2012-09-27

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C67 D09.0

Interventions

Group 1: TURB, resection with wire loop Group 2: TURB, resection with HybridKnife

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Non muscle-invasive bladder cancer Diagnosed by cystoscopy, imaging technique or cytology min. 1 lesion > 0,5 cm

Exclusion criteria

Exclusion criteria: - Age under 18 years. - Persons who are incapable of giving consent. - Pregnancy. - Muscle-invasive cancer. - Multifocal cancer > 5 lesions exceeding 0,5 cm - Tumours which could not be resected completely with both methods (due to technical problems). - Tumours too big to be retrieved endoscopically in one piece. - In case of spacious CIS: Tumours which cannot be completely removed endoscopically - Recent (6-8 weeks) instillation therapy (chemotherapeutics, BCG) - pronounced fibrosis of the bladder (contracted bladder) - Patients who will be treated with early installation therapy

Design outcomes

Primary

Measure	Time frame
Proportion of specimen which can be reliably evaluated pathologically concerning muscle-invasiveness. Data will be gathered on e-questionnaires	—

Secondary

Measure	Time frame
Percentage of en-bloc resections Number each group of proven R0-status In case of Re-TURB: Percentage of tumour-free Re-TURB specimen Percentage of specimen of T1-tumours for which an histological subclassification was possible Determination of Hexvix® tissue penetration Correlation of the spatial expansion of fluorescent marked tissue and tumour-specific histological findings in the cross-sections Data collection: All resected specimen will be investigated by the study-pathologist, data will be gathered on e-questionnaires. After 12 months a PDD-cystoscopy will be conducted, recurrence and progression rate will be documented on e-questionnaires.	—

Measure

Time frame

Percentage of en-bloc resections Number each group of proven R0-status In case of Re-TURB: Percentage of tumour-free Re-TURB specimen Percentage of specimen of T1-tumours for which an histological subclassification was possible Determination of Hexvix® tissue penetration Correlation of the spatial expansion of fluorescent marked tissue and tumour-specific histological findings in the cross-sections Data collection: All resected specimen will be investigated by the study-pathologist, data will be gathered on e-questionnaires. After 12 months a PDD-cystoscopy will be conducted, recurrence and progression rate will be documented on e-questionnaires.

—

Countries

Germany

Contacts

Public ContactJens;Arnulf Mundhenk;Stenzl

Urologische KlinikDiakonissenkrankenhaus und Paulinenhilfe gGmbH Akademisches Lehrkrankenhaus der Universität Tübingen;Universitätsklinikum Tübingen Universitätsklinik für Urologie

mundhenk@diak-stuttgart.de;urologie@med.uni-tuebingen.de0711/991-2301;+49 (0) 7071 2985092

Outcome results

None listed

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