EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules
1 other identifier
interventional
30
1 country
1
Brief Summary
To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 14, 2010
CompletedFirst Posted
Study publicly available on registry
October 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedOctober 15, 2010
March 1, 2010
8 months
October 14, 2010
October 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
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 Outcomes (1)
Efficacy
48 h after intervention
Study Arms (1)
Cryo biospy
EXPERIMENTALInterventions
Cryoprobe, Erbe Company
Eligibility Criteria
You may qualify if:
- solitary pulmonary nodule \< 4 cm
- no endobronchial lesion
- indication for bronchoscopy
You may not qualify if:
- coagulopathy
- pulmonary hypertension
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pneumology and Critical Care medicine
Heidelberg, Baden-Wurttemberg, 69190, Germany
Related Publications (5)
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. doi: 10.1097/JTO.0b013e3181e8b308.
PMID: 20802352BACKGROUNDEberhardt R, Gompelmann D, Herth FJ. Electromagnetic navigation in lung cancer: research update. Expert Rev Respir Med. 2009 Oct;3(5):469-73. doi: 10.1586/ers.09.36.
PMID: 20477337BACKGROUNDEberhardt 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. doi: 10.1159/000232394. Epub 2009 Jul 31.
PMID: 19648733BACKGROUNDEberhardt R, Kahn N, Herth FJ. 'Heat and destroy': bronchoscopic-guided therapy of peripheral lung lesions. Respiration. 2010;79(4):265-73. doi: 10.1159/000284015. Epub 2010 Feb 10.
PMID: 20203535BACKGROUNDSchuhmann M, Bostanci K, Bugalho A, Warth A, Schnabel PA, Herth FJ, Eberhardt R. Endobronchial ultrasound-guided cryobiopsies in peripheral pulmonary lesions: a feasibility study. Eur Respir J. 2014 Jan;43(1):233-9. doi: 10.1183/09031936.00011313. Epub 2013 Jul 30.
PMID: 23900983DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felix JF Herth, MD, PhD
Thoraxklinik, Universityof Heidelberg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 14, 2010
First Posted
October 15, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
October 15, 2010
Record last verified: 2010-03