Endoscopic Resection of Bladder Tumors

NCT ID: NCT01750970

Last Updated: 2016-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Bladder Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Resection under blue light

Group Type EXPERIMENTAL

Endoscopic resection under blue light (Hexvix®)

Intervention Type OTHER

Endoscopic resection

Resection under white light

Group Type ACTIVE_COMPARATOR

Endoscopic resection under blue light (Hexvix®)

Intervention Type OTHER

Endoscopic resection

Interventions

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Endoscopic resection under blue light (Hexvix®)

Endoscopic resection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henry BOTTO, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital FOCH 40, rue Worth 92150 Suresnes

Locations

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Hôpital FOCH

Suresnes, , France

Site Status

Countries

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France

References

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Neuzillet Y, Methorst C, Schneider M, Lebret T, Rouanne M, Radulescu C, Molinie V, Dreyfus JF, Pelcat V, Botto H. Assessment of diagnostic gain with hexaminolevulinate (HAL) in the setting of newly diagnosed non-muscle-invasive bladder cancer with positive results on urine cytology. Urol Oncol. 2014 Nov;32(8):1135-40. doi: 10.1016/j.urolonc.2014.04.005. Epub 2014 Jul 9.

Reference Type DERIVED
PMID: 25023786 (View on PubMed)

Other Identifiers

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2009/34

Identifier Type: -

Identifier Source: org_study_id

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