EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by University of Heidelberg.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Heidelberg

ClinicalTrials.gov Identifier:

NCT01221493

First received: October 14, 2010

Last updated: NA

Last verified: March 2010

History: No changes posted

Purpose

To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions

Condition	Intervention
Yield of Cryo Biopsy in Lung Cancer Solitary Pulmonary Nodule	Procedure: Cryo biopsy

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Safety [ Time Frame: 24 h after intervention ] [ Designated as safety issue: Yes ]
Number of Participants with Adverse Events as a Measure of Safety Detailed analysis of number of Pneumothoraces and number of bleeding complication

Secondary Outcome Measures:

Efficacy [ Time Frame: 48 h after intervention ] [ Designated as safety issue: No ]
Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion

Estimated Enrollment:	30
Study Start Date:	April 2010
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cryo biospy	Procedure: Cryo biopsy Cryoprobe, Erbe Company Other Name: Cryo biopsy probe 20416-032, ERBE company, Germany

Detailed Description:

Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy.

Until now, the use of the cryoprobe ism´t show in peripheral lung tissue.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

solitary pulmonary nodule < 4 cm
no endobronchial lesion
indication for bronchoscopy

Exclusion Criteria:

coagulopathy
pulmonary hypertension
pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221493

Contacts

Contact: Felix JF Herth, MD, PhD	+49-6221 396 ext 1200	felix.herth@thoraxklinik-heidelberg.de
Contact: Ralf Eberhardt, MD	+49 6221-396 ext 8204	ralf.eberhardt@thoraxklinik-heidelberg.de

Locations

Germany
Department of Pneumology and Critical Care medicine	Recruiting
Heidelberg, BW, Germany, 69190
Contact: Felix JF Herth, MD, PhD +49 6221 396 ext 1200 felix.herth@thoraxklinik-heidelberg.de
Principal Investigator: Felix JF Herth, MD, Phd
Sub-Investigator: Ralf Eberhardt, MD

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Felix JF Herth, MD, PhD

Thoraxklinik, Universityof Heidelberg

More Information

Publications:

Eberhardt R, Kahn N, Gompelmann D, Schumann M, Heussel CP, Herth FJ. LungPoint--a new approach to peripheral lesions. J Thorac Oncol. 2010 Oct;5(10):1559-63.

Eberhardt R, Gompelmann D, Herth FJ. Electromagnetic navigation in lung cancer: research update. Expert Rev Respir Med. 2009 Oct;3(5):469-73.

Eberhardt R, Morgan RK, Ernst A, Beyer T, Herth FJ. Comparison of suction catheter versus forceps biopsy for sampling of solitary pulmonary nodules guided by electromagnetic navigational bronchoscopy. Respiration. 2010;79(1):54-60. Epub 2009 Jul 31.

Eberhardt R, Kahn N, Herth FJ. 'Heat and destroy': bronchoscopic-guided therapy of peripheral lung lesions. Respiration. 2010;79(4):265-73. Epub 2010 Feb 10. Review.

Responsible Party:	Felix JF Herth, Thoraxklinik, University of Heidelberg
ClinicalTrials.gov Identifier:	NCT01221493 History of Changes
Other Study ID Numbers:	S-320
Study First Received:	October 14, 2010
Last Updated:	October 14, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

solitary pulmonary nodules
transbronchial lung biopsy
endobronchial ultrasound

Additional relevant MeSH terms:

Lung Neoplasms
Solitary Pulmonary Nodule
Respiratory Tract Neoplasms
Thoracic Neoplasms

Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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