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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary:
Sponsor: Mercator MedSystems, Inc.

Current Primary Outcome:

• Treatment safety [ Time Frame: 12 weeks ]
  Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs)
• Technical success [ Time Frame: procedure day ]
  Device deployment and infusion success

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Airway patency improvements [ Time Frame: 6 weeks ]
• Quality of Life [ Time Frame: 12 weeks ]

Original Secondary Outcome: Same as current

Information By: Mercator MedSystems, Inc.

Dates:
Date Received: February 13, 2014
Date Started: January 2014
Date Completion:
Last Updated: July 10, 2016
Last Verified: July 2016