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Endoscopic Resection of Bladder Tumors

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ClinicalTrials.gov Identifier: NCT01750970
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:
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 or disease Intervention/treatment Phase
Bladder Tumor Other: Endoscopic resection under blue light (Hexvix®) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
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?
Study Start Date : November 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750970


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01750970     History of Changes
Other Study ID Numbers: 2009/34
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases