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Endoscopic Resection of Bladder Tumors

This study has been completed.
Information provided by (Responsible Party):
Hopital Foch Identifier:
First received: December 11, 2012
Last updated: September 20, 2016
Last verified: September 2016
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.

Condition Intervention
Bladder Tumor Other: Endoscopic resection under blue light (Hexvix®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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?

Resource links provided by NLM:

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Number of extra lesions revealed by blue light compared to the resection performed in white light [ Time Frame: 2 to 6 weeks after resection ]

Enrollment: 68
Study Start Date: November 2009
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resection under blue light Other: Endoscopic resection under blue light (Hexvix®)
Endoscopic resection
Active Comparator: Resection under white light Other: Endoscopic resection under blue light (Hexvix®)
Endoscopic resection


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01750970

Hôpital FOCH
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Principal Investigator: Henry BOTTO, MD Hôpital FOCH 40, rue Worth 92150 Suresnes
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hopital Foch Identifier: NCT01750970     History of Changes
Other Study ID Numbers: 2009/34
Study First Received: December 11, 2012
Last Updated: September 20, 2016

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases processed this record on August 17, 2017