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 Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heidelberg University
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

Further study details as provided by Heidelberg University:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Heidelberg University
Investigators
Principal Investigator: Felix JF Herth, MD, PhD Thoraxklinik, Universityof Heidelberg
  More Information

Publications:
Additional 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
Study First Received: October 14, 2010
Last Updated: October 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 15, 2014