Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema

Phase 2

Completed

• Conditions: Emphysema
• Interventions: Device: Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)

• Registration Number: NCT01421082
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. The mechanism of action for these effects is believed to be related to the restoration of elastic recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is to evaluate several physiologic parameters which should provide measures directly related to the mechanism of action by which the coils produce these outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-08-19
• Study First Posted: 2011-08-22
• Study Start: 2012-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Subject > 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria

Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LVRC Treatment	Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)	-

Primary Outcome Measures

Name	Time	Method
6 minute walk test (6MWT)	6 months	The primary effectiveness endpoint will be the improvement in the 6 minute walk test (6MWT) from Baseline compared to Follow-Up.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	6 months	The safety objective of this study is to identify the adverse effects attributed to device.

Trial Locations

Locations (1)

University Medical Center Groningen - UMCG; 🇳🇱 Groningen, The Netherlands, Netherlands