Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

NCT ID: NCT01220908

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-03-31

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.

Conditions

Emphysema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

permanent Coil(s) implant, QOL measure

Coil implantation as treatment. Treatment is permanent implant.

Group Type: EXPERIMENTAL

Lung Volume Reduction Coil (LVRC)

Intervention Type: DEVICE

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

Coils

Intervention Type: DEVICE

Lung Volume Reduction Coil(s)

Interventions

Lung Volume Reduction Coil (LVRC)

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

Intervention Type: DEVICE

Coils

Lung Volume Reduction Coil(s)

Intervention Type: DEVICE

Other Intervention Names

Lung Volume Reduction Surgery (LVRS); Lobectomy; Lung Volume Reduction Surgery (LVRS); Lobectomy

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PneumRx, Inc.

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk-Jan Slebos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Prof. Felix JF Herth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg

Locations

Klinikum Donaustauf

Donaustauf, , Germany

Asklepios

Gauting, , Germany

Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg

Heidelberg, , Germany

Lungenklinik

Hemer, , Germany

University Medical Center Groningen

Groningen, , Netherlands

Countries

Germany; Netherlands

References

Hartman JE, Klooster K, Gortzak K, ten Hacken NH, Slebos DJ. Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema. Respirology. 2015 Feb;20(2):319-26. doi: 10.1111/resp.12435. Epub 2014 Nov 23.

Reference Type: DERIVED

PMID: 25418910 (View on PubMed)

Slebos DJ, Klooster K, Ernst A, Herth FJF, Kerstjens HAM. Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema. Chest. 2012 Sep;142(3):574-582. doi: 10.1378/chest.11-0730.

Reference Type: DERIVED

PMID: 22116796 (View on PubMed)

Other Identifiers

CLN0006

Identifier Type: -

Identifier Source: org_study_id