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Endoscopic Resection of Bladder Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Hopital Foch.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Liliane FALGERE, Hopital Foch
ClinicalTrials.gov Identifier:
NCT01750970
First received: December 11, 2012
Last updated: December 13, 2012
Last verified: October 2009
History of Changes
  Purpose

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: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Rescetion 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 166
Study Start Date: November 2009
Estimated Study Completion Date: February 2013
Primary Completion Date: October 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750970

Contacts
Contact: Henry BOTTO, MD h.botto@hopital-foch.org

Locations
France
Hôpital FOCH Recruiting
Suresnes, France, 92150
Contact: Henry BOTTO, MD         h.botto@hopital-foch.org    
Principal Investigator: Henry BOTTO, MD            
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Henry BOTTO, MD Hôpital FOCH 40, rue Worth 92150 Suresnes
  More Information

No publications provided

Responsible Party: Liliane FALGERE, Administrative coordinator clinical research unit, Hopital Foch
ClinicalTrials.gov Identifier: NCT01750970     History of Changes
Other Study ID Numbers: 2009/34
Study First Received: December 11, 2012
Last Updated: December 13, 2012
Health Authority: France: Direction Générale de la Santé

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

ClinicalTrials.gov processed this record on May 23, 2013