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Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563730
Recruitment Status : Unknown
Verified October 2016 by Boeckeler, Michael, University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Boeckeler, Michael, University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE May 2, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy [ Time Frame: two weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • numer of bleeding events [ Time Frame: 1 day ]
  • Rate of pneumothoraxes [ Time Frame: 1 day ]
  • numer of exacerbations after biopsy [ Time Frame: 6 weeks ]
  • Contribution of BAL and cryobiopsy to diagnosis [ Time Frame: 2 weeks ]
  • Size of specimen [ Time Frame: 2 weeks ]
  • Quality of specimen [ Time Frame: 2 weeks ]
  • Distribution of histological changes in the specimen [ Time Frame: 2 weeks ]
  • Influence of the size of the cryoprobe in the primary endpoint [ Time Frame: 2 weeks ]
  • Comparative group (out of trial) - who are referred for VATS directly ['positive control group'] [ Time Frame: 6 weeks ]
  • Rate of exacerbations after cryobiopsy and after surgical biopsy [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
Official Title  ICMJE Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
Brief Summary A multicenter, multinational, prospective study to clarify, whether the addition of cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients with suspected Idiopathic Interstitial Pneumonia
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Interstitial Lung Disease
Intervention  ICMJE Procedure: Lung biopsy
transbronchial lung biopsy. First kryobiopsy, second open biopsy
Study Arms  ICMJE Experimental: Lung biopsy
assess the additional diagnostic value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia (IIP). Cryoprobe vs VATS
Intervention: Procedure: Lung biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 28, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • IIP suspected on clinical and radiologic grounds

Exclusion Criteria:

  • Age >80y and <18y
  • FVC< 55%, DCO<35%
  • Platelet count <100000/µl
  • acetylsalicylic acid, clopidogrel or equivalent during the last 5 days
  • INR > l,3,
  • elevated PTT (> 40 s)
  • documented pulmonary hypertension PAPS >50mmHg
  • HR-CT highly suspicious for sarcoidosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563730
Other Study ID Numbers  ICMJE CRYO-VATS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boeckeler, Michael, University Hospital Tuebingen
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital Tuebingen
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP