TruFreeze™ Airway Obstruction: TAO STUDY

The purpose of this study is to prospectively assess the efficacy and safety of spray cryotherapy ablation with the truFreeze System in conjunction with mechanical dilation or debridement for the treatment of clinically significant obstructions of the central airways. The primary effectiveness endpoint is the proportion of subjects with a minimum of 25% improvement in luminal patency following SCT treatment and mechanical intervention 30 days (+/- 5 days) following treatment. Additionally, a primary clinical safety endpoint is the reporting of all adverse events.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Subjects with symptomatic, clinically significant central airway obstruction requiring treatment intervention and who are not candidates for surgical resection. The central airway obstruction must be a consequence of any of the following:

   1. Benign airway strictures
   2. Primary or secondary endobronchial tumors located in the central airways
   3. Airway stents complicated by significant granulation tissue
2. Subjects (or designated proxies) who are able to provide written informed consent
3. Subjects aged 18 years or greater
4. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
5. Subjects deemed eligible candidates for spray cryotherapy based on medical history and physical exam

Exclusion Criteria:

1. Subjects undergoing treatment with any other investigational therapy within the month preceding cryotherapy or planned within 1 month following treatment

   a. Subjects with malignant strictures who require chemotherapy/radiation therapy (including investigational therapies) within 30 days will be allowed participation in the study.
2. Subjects with extraluminal causes of airway obstruction such as bulky mediastinal adenopathy, or a central mediastinal tumor causing compression of the airway
3. Subjects with less than 3 month expected survival
4. Subjects who it is anticipated will require stent placement during their initial treatment
5. Subjects who are pregnant or nursing, per device instructions for use
6. Subjects (or a designated proxy) who are unwilling to provide written informed consent
7. Subjects with ECOG performance status greater than 3
8. Subjects likely to have difficulty complying with study visit follow-up scheduling
9. Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up
10. Subjects with uncontrolled coagulopathy or other bleeding disorders

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• BACKGROUNDGreenwald BD, Dumot JA, Abrams JA, Lightdale CJ, David DS, Nishioka NS, Yachimski P, Johnston MH, Shaheen NJ, Zfass AM, Smith JO, Gill KR, Burdick JS, Mallat D, Wolfsen HC. Endoscopic spray cryotherapy for esophageal cancer: safety and efficacy. Gastrointest Endosc. 2010 Apr;71(4):686-93. doi: 10.1016/j.gie.2010.01.042. PMID 20363410
• BACKGROUNDXue HB, Tan HH, Liu WZ, Chen XY, Feng N, Gao YJ, Song Y, Zhao YJ, Ge ZZ. A pilot study of endoscopic spray cryotherapy by pressurized carbon dioxide gas for Barrett's esophagus. Endoscopy. 2011 May;43(5):379-85. doi: 10.1055/s-0030-1256334. Epub 2011 Mar 24. PMID 21437849
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