Back to resultsEndoscopic Resection of Bladder Tumors
Primary Purpose
Bladder Tumor
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endoscopic resection under blue light (Hexvix®)
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Tumor
Eligibility 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
Sites / Locations
- Hôpital FOCH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Resection under blue light
Resection under white light
Arm Description
Outcomes
Primary Outcome Measures
Number of extra lesions revealed by blue light compared to the resection performed in white light
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01750970
Brief Title
Endoscopic Resection of Bladder Tumors
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 Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resection under blue light
Arm Type
Experimental
Arm Title
Resection under white light
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Endoscopic resection under blue light (Hexvix®)
Intervention Description
Endoscopic resection
Primary Outcome Measure Information:
Title
Number of extra lesions revealed by blue light compared to the resection performed in white light
Time Frame
2 to 6 weeks after resection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry BOTTO, MD
Organizational Affiliation
Hôpital FOCH 40, rue Worth 92150 Suresnes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital FOCH
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25023786
Citation
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.
Results Reference
derived
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Endoscopic Resection of Bladder Tumors
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