Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT01903850
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01903850
Study Brief:
Protocol Section:
NCT01903850