Endoscopic Resection of Bladder Tumors

Hopital Foch

Status: Completed

Conditions: Bladder Tumor

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01750970

2009/34

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Resection under blue light

Experimental group

Treatment:

Other: Endoscopic resection under blue light (Hexvix®)

Resection under white light

Active Comparator group

Treatment:

Other: Endoscopic resection under blue light (Hexvix®)