Endoscopic Resection of Bladder Tumors

• Sponsor: Hopital Foch (Other)
• Overall Status: Completed
• CT.gov ID: NCT01750970
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Tumor	Other: Endoscopic resection under blue light (Hexvix®)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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?
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Resection under blue light	Other: Endoscopic resection under blue light (Hexvix®); Endoscopic resection
Active Comparator: Resection under white light	Other: Endoscopic resection under blue light (Hexvix®); Endoscopic resection

Outcome Measures

Primary Outcome Measures

1. Number of extra lesions revealed by blue light compared to the resection performed in white light [2 to 6 weeks after resection]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital FOCH	Suresnes		France	92150

Sponsors and Collaborators

• Hopital Foch

Investigators

• Principal Investigator: Henry BOTTO, MD, Hôpital FOCH 40, rue Worth 92150 Suresnes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT01750970
• Other Study ID Numbers: 2009/34
• First Posted: Dec 17, 2012
• Last Update Posted: Sep 21, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Sep 21, 2016