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EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

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ClinicalTrials.gov Identifier: NCT01221493
Recruitment Status : Unknown
Verified March 2010 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : October 15, 2010
Last Update Posted : October 15, 2010
Sponsor:
Information provided by:
Heidelberg University

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

Condition or disease Intervention/treatment Phase
Yield of Cryo Biopsy in Lung Cancer Solitary Pulmonary Nodule Procedure: Cryo biopsy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : April 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cryo biospy Procedure: Cryo biopsy
Cryoprobe, Erbe Company
Other Name: Cryo biopsy probe 20416-032, ERBE company, Germany



Primary Outcome Measures :
  1. Safety [ Time Frame: 24 h after intervention ]
    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 :
  1. Efficacy [ Time Frame: 48 h after intervention ]
    Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • coagulopathy
  • pulmonary hypertension
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Heidelberg University
Investigators
Principal Investigator: Felix JF Herth, MD, PhD Thoraxklinik, Universityof Heidelberg

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Felix JF Herth, Thoraxklinik, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01221493     History of Changes
Other Study ID Numbers: S-320
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: October 15, 2010
Last Verified: March 2010

Keywords provided by Heidelberg University:
solitary pulmonary nodules
transbronchial lung biopsy
endobronchial ultrasound

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases