Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mercator MedSystems, Inc.
With
National Cancer Institute (NCI)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Life expectancy of at least 12 weeks
Adequate bone marrow, liver, and renal function
Scheduled to undergo bronchoscopy for malignant airway obstruction as standard medical care
Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
Measurable disease with obstruction into the airway
Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
Patients undergo recanalization procedure of tumor during bronchoscopy
Investigator is able to insert and deploy the Blowfish Catheter into the airway after recanalization
You may not be if
Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy test prior to their enrollment in this study
Uncontrolled infection
Presence or recent history of any systemic disorder or conditions, such as:
* uncontrolled hypertension
* type 1 diabetes
* severe pulmonary hypertension
* acute kidney injury
* stroke (within the last 6 month)
* myocardial infarction (within the last 3 months)
Individuals with neurological, mental or psychiatric disorders
Concurrent participation in another study involving investigational drugs or investigational medical devices
Other (non-cancer) disease not stabilized within 1 month before the Screening Visit
Known hypersensitivity to paclitaxel, Cremophor EL, or iodinated contrast media
Use of pulmonary airway stents and/or ongoing or initiation of local external beam or brachytherapy radiation
Any intraoperative complications that per the investigator's judgment increase the risk to the patient.
