Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01220908

Enrollment

Registered

2010-10-14

Start date

2008-01-31

Completion date

2012-03-31

Last updated

2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emphysema

Keywords

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

Brief summary

The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.

Interventions

DEVICELung Volume Reduction Coil (LVRC)

Implantation of Lung Volume Reduction Coil(s) (LVRC)

DEVICECoils

Lung Volume Reduction Coil(s)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Patient \> 35 years of age * unilateral or bilateral emphysema * Patient has stopped smoking for a minimum of 8 weeks * Read, understood and signed the Informed Consent form

Exclusion criteria

* Patient has a history of recurrent clinically significant respiratory infection * Patient has an inability to walk \>140 meters * Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc * Patient is pregnant or lactating * Patient has clinically significant bronchiectasis * Patient has had previous LVR surgery, lung transplant or lobectomy * Patient has been involved in other pulmonary drug studies with 30 days prior to this study * Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Design outcomes

Primary

Measure	Time frame	Description
Quality of Life Assessment.	Three + Months Follow-Up Visit	Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ)

Countries

Germany, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026