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Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients

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Trial Conditions
  • Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer
What is the purpose of this trial?

Assess the safety and feasibility of local oncological drug delivery into the bronchial wall after recanalization of subjects with malignant airway obstruction. Safety and feasibility (technical success) will be assessed. This localized delivery is intended as an adjunct therapy and all subjects will receive standard of care oncology therapy as determined by their treating physicians.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Any serious, uncontrolled comorbidity or condition that an Investigator believes
would interfere with the intent of the study or would make participation not in the
best interest of the patient Intraoperative Exclusion Criteria

- 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.

Gender: Both
Trial Interventions
Drug
  • Paclitaxel
Other Information

Sponsor: Mercator MedSystems, Inc.
Phase: N/A
Trial ID: NCT02066103
Volunteers:  Not Accepting Healthy Volunteers

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