Health TrialsbyHealthPanel

Blue Light Cystoscopy With Cysview® Registry

ConditionBladder Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPhotocure

About this trial

Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult >18 years old

Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy

Disqualifiers

Porphyria

Gross hematuria

Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives

Trial population

Patients indicated for transurethral resection of the bladder.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Hexaminolevulinate hydrochloride (HCL)

    Drug

    Instillation in bladder

  • Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

    Device

    Cystoscopy procedure

Treatment groups

4,400 Participants
are divided into 1 treatment group
Group A: Blue Light Cystoscopy with Cysview®2 interventions

Trial outcomes

Primary outcomes

1

Rate of detection of bladder malignancies

Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone.

Time frame
5 years

Secondary outcomes

1

False-positive detection rates

Rates of false-positive lesion biopsies based on pathological findings

Time frame
5 years
2

Higher-Quality resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone

Rate of additional margin detection with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone

Time frame
5 years
3

Proportion of patients with adverse events considered causally related to Cysview in repeat administration.

Adverse events reporting

Time frame
5 years
4

Recurrence Rates

Recurrence rates NMIBC in patients whose lesions were detected with Blue Light Cystoscopy with Cysview

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Photocure

Lead sponsor

Catalyst Pharmaceutical Research

Collaborator

Source ClinicalTrials.gov
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