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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?


N/A
18 Years
N/A
Open (Enrolling)
Both
Bladder Tumor

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Trial Information

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?


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of extra lesions revealed by blue light compared to the resection performed in white light

Outcome Time Frame:

2 to 6 weeks after resection

Safety Issue:

No

Principal Investigator

Henry BOTTO, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hôpital FOCH 40, rue Worth 92150 Suresnes

Authority:

France: Direction Générale de la Santé

Study ID:

2009/34

NCT ID:

NCT01750970

Start Date:

November 2009

Completion Date:

February 2013

Related Keywords:

  • Bladder Tumor
  • Urinary Bladder Neoplasms

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