Endoscopic Resection of Bladder Tumors

Bladder Tumor Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750970
• Other study ID #: 2009/34
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: September 20, 2016
• Start date: November 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bladder Tumor
• Urinary Bladder Neoplasms

Intervention

Other:
• Endoscopic resection under blue light (Hexvix®)
Endoscopic resection

Locations

Country	Name	City	State
France	Hôpital FOCH	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of extra lesions revealed by blue light compared to the resection performed in white light		2 to 6 weeks after resection	No