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

NCT01421082 | Completed Phase 2

• 1 other identifier: CLN0012
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Emphysema

Keywords

LVRS (Lung Volume Reduction Surgery); LVRC (Lung Volume Reduction Coil); Emphysema; coil; RePneu

Outcome Measures

Primary Outcomes (1)

• 6 minute walk test (6MWT)

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

  6 months

Secondary Outcomes (1)

• Adverse Events

  6 months

Study Arms (1)

LVRC Treatment

EXPERIMENTAL

Device: Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)

Interventions

Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.) DEVICE

Lung Volume Reduction Coil (LVRC)

Also known as: Lung Volume Reduction Surgery (LVRS), Lobectomy

LVRC Treatment

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• PneumRx, Inc.: collaborator

Study Sites (1)

University Medical Center Groningen - UMCG

Groningen, The Netherlands, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Emphysema

Interventions

Pneumonectomy; Anterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Neurosurgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 22, 2011
• Study Start: February 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

NL (1)