Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GE Healthcare |
---|---|
Information provided by: | GE Healthcare |
ClinicalTrials.gov Identifier: | NCT00634621 |
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.
Condition | Intervention |
---|---|
Non-Invasive Bladder Cancer |
Drug: Hexaminolevulinate (Hexvix) |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | 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. |
Estimated Enrollment: | 300 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with documented or suspected bladder cancer.
Inclusion Criteria:
Exclusion Criteria:
Contact: Dr. A.Javier González Calvo | +34 91 623 39 17 | AlfonsoJavier.GonzálezCalvo@ge.com |
Spain | |
GE Healthcare | Recruiting |
Madrid, Spain, 28108 | |
Contact: Dr. A.Javier González Calvo +34 91 623 39 17 AlfonsoJavier.GonzálezCalvo@ge.com |
Principal Investigator: | Dr. Carlos Hernández | Gregorio Marañón Hospital, Madrid |
Principal Investigator: | Dr. Eduardo Solsona | Valencian Institute of Oncology, Valencia |
Principal Investigator: | Dr. Joan Palou | Fundación Puigvert, Barcelona |
Responsible Party: | GE Healthcare ( Emilio Moreno/Medical Director Region 4 ) |
Study ID Numbers: | GEH-HEX-2007-01 |
Study First Received: | February 26, 2008 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00634621 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Bladder Cancer Cystoscopy Hexaminolevulinate Hexvix |
Urinary Tract Neoplasm Cystocele Urologic Diseases Urinary Bladder Diseases |
Urinary Bladder Neoplasms Urogenital Neoplasms Bladder Neoplasm Urologic Neoplasms |
Neoplasms Neoplasms by Site Urologic Diseases Urinary Bladder Diseases |
Urinary Bladder Neoplasms Urogenital Neoplasms Urologic Neoplasms |