Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease

This study has been terminated.

Sponsor:

Information provided by:

University Hospital, Tours

ClinicalTrials.gov Identifier:

NCT00241267

First received: October 14, 2005

Last updated: October 5, 2006

Last verified: May 2006

History of Changes

Purpose

The exploration of neoplastic pulmonary pathology is based on computed tomography and bronchoscopy. This allows targeted samples of the identified lesions.

A new ultrasonographic method is proposed as a non invasive and non irradiating technic by using a dedicated probe easily introduced via the channel of the fibrescope, so as to complete the identification of peripheral lesions.

Condition	Intervention
Pulmonary Neoplasms	Device: Dedicated ultrasonographic probe during bronchoscopy

Study Type:	Observational
Study Design:	Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective
Official Title:	Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by University Hospital, Tours:

Estimated Enrollment:	20
Study Start Date:	March 2005
Estimated Study Completion Date:	March 2006

Detailed Description:

The main objective of the study is to assess the ability of endobronchial ultrasonography to diagnose peripheral pulmonary lesions during the bronchoscopy and to correlate the abnormalities to computed tomography and/or histology.

The dedicated probe consist of a linear array of 2-3 mm in diameter connected to a commercial unit.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Assumed proximal neoplastic pulmonary pathology
Planned bronchoscopy and biopsy

Exclusion Criteria:

Pregnancy
Breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241267

Locations

France
University Hospital of TOURS
Tours, France, 37044

Sponsors and Collaborators

University Hospital, Tours

Investigators

Principal Investigator:

François TRANQUART, PR

Centre d'Innovation Technologique

More Information

Publications:

Baba M, Sekine Y, Suzuki M, Yoshida S, Shibuya K, Iizasa T, Saitoh Y, Onuma EK, Ohwada H, Fujisawa T. Correlation between endobronchial ultrasonography (EBUS) images and histologic findings in normal and tumor-invaded bronchial wall. Lung Cancer. 2002 Jan;35(1):65-71.

Falcone F, Fois F, Grosso D. Endobronchial ultrasound. Respiration. 2003 Mar-Apr;70(2):179-94. Review.

Kurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65.

ClinicalTrials.gov Identifier:	NCT00241267 History of Changes
Other Study ID Numbers:	CT04-FT/ENDO
Study First Received:	October 14, 2005
Last Updated:	October 5, 2006
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:

Pulmonary
Neoplasms
Endobronchial
Ultrasonography
Primary

Additional relevant MeSH terms:

Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms

Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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