At a glance
ClinicalIndex Comparison RecordN/ACompleted· 283 enrolled
Drug / intervention
Hexaminolevulinate (Hexvix)drug
Likely dose
Hexaminolevulinate (Hexvix) 50 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Post-authorization, Observational Study to Assess the Impact of Blue Light Cystoscopy After Administration of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer.
In Brief
An observational study evaluating Hexaminolevulinate (Hexvix) for Bladder Cancer. Completed, enrolled 283 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the effectiveness of hexaminolevulinate (Hexvix) in the diagnosis and treatment of patients with non-invasive bladder cancer and if it results in a change in patient management.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesSpain
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedMar 2008
Primary CompletionSep 2010
TodayJul 2026
First PostedMar 13, 2008
Enrollment StartFeb 1, 2008
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.3 years ago
Interventions
Hexaminolevulinate (Hexvix)drug
Each patient enrolled into the study will be infused with 50 mL of a 2 mg/mL Hexvix solution in the bladder using a catheter. Subsequently, after fluid retention by the patient in the bladder for one hour, the bladder will be emptied.