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Endoscopic Resection of Bladder Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750970
First Posted: December 17, 2012
Last Update Posted: September 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
December 11, 2012
December 17, 2012
September 21, 2016
November 2009
December 2012   (Final data collection date for primary outcome measure)
Number of extra lesions revealed by blue light compared to the resection performed in white light [ Time Frame: 2 to 6 weeks after resection ]
Same as current
Complete list of historical versions of study NCT01750970 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Endoscopic Resection of Bladder Tumors
Endoscopic Resection of High Grade(TA, T1, Cis)Non-muscle Invasive Bladder Tumors: Modification of Usual Management of This Resection by Using the Blue Light and Evaluation of the Outcome: Should we Maintain the Dogma of Second Endoscopic Resection as a Principle?
To confirm the benefit of endoscopic resection under fluorescence and blue light of high grade non-muscle invasive bladder tumor, and verifying if the second endoscopic resection recommended nowadays can be deleted.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bladder Tumor
Other: Endoscopic resection under blue light (Hexvix®)
Endoscopic resection
  • Experimental: Resection under blue light
    Intervention: Other: Endoscopic resection under blue light (Hexvix®)
  • Active Comparator: Resection under white light
    Intervention: Other: Endoscopic resection under blue light (Hexvix®)
Neuzillet Y, Methorst C, Schneider M, Lebret T, Rouanne M, Radulescu C, Molinie V, Dreyfus JF, Pelcat V, Botto H. Assessment of diagnostic gain with hexaminolevulinate (HAL) in the setting of newly diagnosed non-muscle-invasive bladder cancer with positive results on urine cytology. Urol Oncol. 2014 Nov;32(8):1135-40. doi: 10.1016/j.urolonc.2014.04.005. Epub 2014 Jul 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
December 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

- 18 year-old and older male and female subjects having high grade non-muscle invasive bladder tumor, with urinary cytology , imaging examination (Ultrasound, urography, or scan) and endoscopic examination

Exclusion Criteria:

- Less than 18 years of age, and having no:

  • Non-muscle invasive tumor, and of low grade.
  • Bladder tumor infiltrating the muscular layer shown by pre-operative test, with absence of urinary cytology
  • No blue light source in sustainable way
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01750970
2009/34
No
Not Provided
Not Provided
Hopital Foch
Hopital Foch
Not Provided
Principal Investigator: Henry BOTTO, MD Hôpital FOCH 40, rue Worth 92150 Suresnes
Hopital Foch
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP