Endoscopic Resection of Bladder Tumors

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.

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Key information

Conditions

Bladder Tumor Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital FOCH

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic resection under blue light (Hexvix®)

Other

Endoscopic resection

Primary outcomes

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

Time frame: 2 to 6 weeks after resection

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study 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?

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2013
First posted: Dec 17, 2012
Registry last updated: Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed