Detection of Bladder Tumors After 30 Min Instillation of Hexvix

NCT01551407 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2012-10-25

No results posted yet for this study

Summary

The objective of the study is to compare Hexvix® flexible cystoscopy and white light flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined as dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.

Conditions

Interventions

DRUG

Hexvix

50 ml Hexvix liquid instilled once into the bladder for 30 minutes prior to cystoscopy

Sponsors & Collaborators

  • Photocure

    lead INDUSTRY

Principal Investigators

  • Alexander Karl, MD · Department of Urology, LMU Munich, Germany

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01551407 on ClinicalTrials.gov