NCT01972685 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Aktas Z, Gunay E, Hoca NT, Yilmaz A, Demirag F, Gunay S, Sipit T, Kurt EB
Endobronchial cryobiopsy or forceps biopsy for lung cancer diagnosis. Ann Thorac Med. 2010 Oct;5(4):242-6. doi: 10.4103/1817-1737.69117.
Babiak A, Hetzel J, Krishna G, Fritz P, Moeller P, Balli T, Hetzel M
Transbronchial cryobiopsy: a new tool for lung biopsies. Respiration. 2009;78(2):203-8. doi: 10.1159/000203987. Epub 2009 Feb 21.
Deshmukh SP, Krasna MJ, McLaughlin JS
Video assisted thoracoscopic biopsy for interstitial lung disease. Int Surg. 1996 Oct-Dec;81(4):330-2.
Griff S, Ammenwerth W, Schönfeld N, Bauer TT, Mairinger T, Blum TG, Kollmeier J, Grüning W
Morphometrical analysis of transbronchial cryobiopsies. Diagn Pathol. 2011 Jun 16;6:53. doi: 10.1186/1746-1596-6-53. Erratum in: Diagn Pathol. 2016;11(1):64.
Krasna MJ, Deshmukh S, McLaughlin JS
Complications of thoracoscopy. Ann Thorac Surg. 1996 Apr;61(4):1066-9.
Krasna MJ, White CS, Aisner SC, Templeton PA, McLaughlin JS
The role of thoracoscopy in the diagnosis of interstitial lung disease. Ann Thorac Surg. 1995 Feb;59(2):348-51.
Yarmus L, Akulian J, Gilbert C, Illei P, Shah P, Merlo C, Orens J, Feller-Kopman D
Cryoprobe transbronchial lung biopsy in patients after lung transplantation: a pilot safety study. Chest. 2013 Mar;143(3):621-626. doi: 10.1378/chest.12-2290.

Comparison of Transbronchial, Cryoprobe and VATS Biopsy For the Diagnosis of Interstitial Lung Disease (ILD)

Clinical trial NCT01972685 - References