Endoscopic Resection of Bladder Tumors

Not Applicable

Completed

• Conditions: Bladder Tumor
• Interventions: Other: Endoscopic resection under blue light (Hexvix®)

• Registration Number: NCT01750970
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2012-12
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Study Completion: 2013-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resection under white light	Endoscopic resection under blue light (Hexvix®)	-
Resection under blue light	Endoscopic resection under blue light (Hexvix®)	-

Primary Outcome Measures

Name	Time	Method
Number of extra lesions revealed by blue light compared to the resection performed in white light	2 to 6 weeks after resection

Trial Locations

Locations (1)

Hôpital FOCH; 🇫🇷 Suresnes, France