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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00241267
Other study ID # CT04-FT/ENDO
Secondary ID
Status Terminated
Phase N/A
First received October 14, 2005
Last updated October 5, 2006
Start date March 2005
Est. completion date March 2006

Study information

Verified date May 2006
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Assumed proximal neoplastic pulmonary pathology

- Planned bronchoscopy and biopsy

Exclusion Criteria:

- Pregnancy

- Breastfeeding

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Intervention

Device:
Dedicated ultrasonographic probe during bronchoscopy


Locations

Country Name City State
France University Hospital of TOURS Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (3)

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 — View Citation

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

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. — View Citation

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