Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases
![]() |
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: NCT01714518 |
Recruitment Status :
Completed
First Posted : October 26, 2012
Last Update Posted : October 29, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Interstitial Lung Disease |
Study Type : | Observational |
Actual Enrollment : | 62 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Cryobiopsy vs. VATS: Efficiency and Safety in the Diagnosis of Interstitial Lung Diseases |
Actual Study Start Date : | October 16, 2012 |
Actual Primary Completion Date : | June 30, 2017 |
Actual Study Completion Date : | June 30, 2017 |

Group/Cohort |
---|
ILD diagnosis
Patients subjected to Cryobiopsy and/or VATS for diagnosis of interstitial lung disease
|
- Rate of diagnostic cryobiopsies [ Time Frame: up to 3 days ]For the individual study participant, the result of the cryobiopsy (whether it is diagnostically helpful, i.e. "diagnostic" or not, i.e. "inconclusive") will be documented when it is available, which will be within 3 days. The overall number of diagnostic cryobiopsies will be calculated once the study is complete.
- Rate of complications during cryobiopsy [ Time Frame: During and up to 48 hours after procedure ]Number of complications associated with cryobiopsy, divided into three categories of severity: mild/moderate/severe
- Rate of complications during VATS [ Time Frame: During and up to 10 days after procedure ]Number of complications associated with VATS, divided into three categories of severity: mild/moderate/severe

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Age ≥ 18 years
- Known or newly diagnosed interstitial lung disease (ILD)
- Indication for lung biopsy for definitive ILD diagnosis
- Informed Consent provided
Exclusion Criteria:
- Age < 18 years
- Inability or contraindication to undergo any form of invasive diagnostic procedure associated with diagnosis of interstitial lung disease
- Severely restricted CO diffusion capacity (<50%)
- Pregnancy, lactation
- Any medical, psychological or other condition restricting the patient's ability to provide informed consent
- Participation in another clinical trial

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): NCT01714518
Germany | |
Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine | |
Solingen, NRW, Germany, 42699 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Wissenschaftliches Institut Bethanien e.V |
ClinicalTrials.gov Identifier: | NCT01714518 |
Other Study ID Numbers: |
WI_KryoVATS_80/2012 |
First Posted: | October 26, 2012 Key Record Dates |
Last Update Posted: | October 29, 2018 |
Last Verified: | October 2018 |
Interstitial Lung Disease Diagnosis Cryobiopsy Video-assisted thoracic surgery Lung biopsy |
Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases |