NCT03360396

Brief Summary

This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
6 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 4, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 3, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

November 22, 2017

Results QC Date

April 12, 2021

Last Update Submit

August 2, 2023

Conditions

Emphysema

Keywords

severe heterogeneous emphysemasevere homogeneous emphysema

Outcome Measures

Primary Outcomes (2)

  • Percent Change in FEV1 at 6 Months

    Percent change in FEV1

    6 months

  • Absolute Change in SGRQ Score at 6 Months

    Change in SGRQ score - St. George Respiratory Questionnaire from 0 to 100, higher score indicating more limitations (worse), increase in score indicating worse outcome, decrease in score indicating improvement

    6 months

Study Arms (2)

Endobronchial Coils

EXPERIMENTAL

Treatment with PneumRx Endobronchial Coil System

Device: Endobronchial Coils

Control

NO INTERVENTION

Medically-managed control group

Interventions

Endobronchial CoilsDEVICE

Endobronchial Coil implants

Endobronchial Coils

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Read, understood and signed the Informed Consent form
  • Meets indications for use per the IFU
  • Bilateral heterogeneous and/or homogeneous emphysema
  • Post bronchodilator 15% predicted ≤ Forced Expiratory Volume in 1 second (FEV1) ≤ 45% predicted
  • Post bronchodilator Residual Volume (RV) ≥ 200% predicted
  • Post bronchodilator Total Lung Capacity (TLC) \>100% pred.
  • Post bronchodilator RV/TLC \> 55%
  • Dyspnea related to hyperinflation scored ≥ 2 on modified Medical Research Council (mMRC) dyspnea scale despite optimal medical management
  • Receiving optimal drug therapy and medical management according to clinical practice.
  • Performing regular physical activity, at least 2 times per week
  • Stopped smoking as confirmed by carboxyhemoglobin (CoHB)
  • m ≤ 6 minute walk distance (6MWD) ≤ 450m
  • Deemed eligible per Eligibility Review Committee (ERC)
  • if treated in France, subject must be entitled to French social security.

You may not qualify if:

  • Known sensitivity to drugs required for performing bronchoscopy or in whom bronchoscopic procedures are contraindicated
  • Evidence of active infection in the lungs
  • Hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent metals
  • Clinical significant pulmonary fibrosis
  • Clinically significant, generalized bronchiectasis
  • Clinically significant bleeding disorders
  • Patient taking immunosuppressive drugs other than steroids (e.g., for the treatment of cancer, rheumatoid arthritis, autoimmune disease, or prevention of tissue or organ rejection).
  • Primary diagnosis of asthma
  • Two (2) or more COPD exacerbations in the prior year, or 1 or more COPD exacerbations in the prior 3 months with indication for hospitalization assessment, according to GOLD 2017 recommendations .
  • Predominant small airways disease defined as significant bronchiectasis with sputum production (\> 2 tablespoons daily) or significant bronchial wall thickening per High Resolution Computed Tomography (HRCT)
  • Percent Low Attenuation Area (%LAA) \< 20% in the most damaged lobe of either lung.
  • Computed Tomography (CT) Imaging consistent with active pulmonary infection, significant interstitial disease or pleural disease
  • Severe bullous disease (defined by bulla \> 8cm or 1/3 of lung volume, or single bullous defect \>8 cm) or predominant paraseptal emphysema \[defined by numerous large (\>1cm) paraseptal defects in the target lobe comprising of \>5% of total lung volume\].
  • Lung pathology of nodule not proven stable or benign
  • Radiographic confirmation of atelectasis or other scarring/fibrosis in areas of intended Coil implant
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie

Vienna, Austria

Location

CHU Grenoble

Grenoble, France

Location

CHU Montpellier

Montpellier, France

Location

Centre Hospitalier Universitaire de Nice

Nice, CS 51069, France

Location

Hôpital Bichat

Paris, France

Location

CHU de Reims - Hopital Maison Blanche

Reims, 51092, France

Location

Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Charite Berlin - Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie

Berlin, Germany

Location

Gemeinschaftskrankenhaus Havelhöhe GmbH

Berlin, Germany

Location

Universitätsklinkum Bonn

Bonn, Germany

Location

Ruhrlandklinik Essen

Essen, Germany

Location

Thoraxklinik

Heidelberg, Germany

Location

Lungenklinik

Hemer, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

Location

Klinikverbund Kempten-Oberallgäu

Immenstädt, Germany

Location

Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH

Stuttgart, Germany

Location

Ospedale Careggi

Florence, Italy

Location

University Medical Center Groningen

Groningen, 3150-3610536, Netherlands

Location

Royal Brompton Hospital

London, United Kingdom

Location

Related Publications (1)

  • Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

    PMID: 33590989DERIVED

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jessica Stockwell
Organization
Boston Scientific Corporation
Jessie.Stockwell@bsci.com
612-618-1136

Study Officials

  • Felix Herth, MD,

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

  • Arschang Valipour, MD,FCCP,PhD

    Nord-Klinik Floridsdorf

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2017

First Posted

December 4, 2017

Study Start

May 7, 2018

Primary Completion

February 26, 2020

Study Completion

November 22, 2022

Last Updated

August 28, 2023

Results First Posted

November 3, 2021

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)DE(9)IT(1)NL(1)AU(1)GB(1)