EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

October 14, 2010 updated by: Heidelberg University
To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • BW
      • Heidelberg, BW, Germany, 69190
        • Recruiting
        • Department of Pneumology and Critical Care medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • coagulopathy
  • pulmonary hypertension
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryo biospy
Procedure: Cryo biopsy
Cryoprobe, Erbe Company
Other Names:
  • Cryo biopsy probe 20416-032, ERBE company, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 h after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 48 h after intervention
Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion
48 h after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Felix JF Herth, MD, PhD, Thoraxklinik, Universityof Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 14, 2010

First Posted (Estimate)

October 15, 2010

Study Record Updates

Last Update Posted (Estimate)

October 15, 2010

Last Update Submitted That Met QC Criteria

October 14, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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