NCT00884962

A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Aeris Therapeutics · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments, respectively. All patients will receive treatment in a single lung under conscious sedation or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to be retreated at additional sites so that their total dose received is consistent with the effective dose. All study patients will receive standard medical therapy in addition to PLVR.

Conditions

• Advanced Emphysema

Interventions

Type	Name	Description
DEVICE	Polymeric Lung Volume Reduction System (PLVR)	20ml (each) of polymer will be injected into 2, 3 or 4 subsegments during the first treatment. Eligible patients may have 20ml (each) of polymer will be injected into 2 or 3 subsegments during the second treatment.

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-04-21
• Last updated: 2011-10-21

Locations

6 sites across 1 country: Germany