Long Term Follow up Investigation of Endobronchial Valves in Emphysema

NCT01580215 | Terminated DMC

• 1 other identifier: 630-0013
• Study Type: observational
• Target: 628
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.

Conditions

Pulmonary Emphysema

Keywords

Valves; Endobronchial; Endoscopic lung volume reduction; Pulmonx; Zephyr; Chartis; Emphysema; COPD

Outcome Measures

Primary Outcomes (1)

• FEV1

  Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)

  2 years

Secondary Outcomes (3)

• Modified Medical Research Council (mMRC) Questionnaire

  5 years

• COPD Assessment Test (CAT)

  5 years

• Survival over 5 years

  5 years

Other Outcomes (1)

• Adverse Events

  5 years

Study Arms (1)

Main cohort

* Patients of both genders of at least 18 years of age * Who understand and voluntarily sign an informed consent form * FEV1 \> 15% predicted and \< 45% predicted * RV \>180% predicted * Diagnosis of emphysema with CT evidence of hyperinflation * Absence of collateral ventilation according to Chartis Assessment System * Treated with Zephyr Endobronchial Valve (EBV)

Device: Zephyr Endobronchial Valve (EBV)

Interventions

Zephyr Endobronchial Valve (EBV) DEVICE

• Implantation of at least one Zephyr EBV following Chartis assessment

Main cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient participation is entirely voluntary. Patients must meet the inclusion/exlusion criteria to be eligible for the study.

You may qualify if:

• Patients of both genders of at least 18 years of age
• Understand and voluntarily sign an informed consent form.
• FEV1 \> 15% predicted and \< 45% predicted
• RV \>180% predicted
• Diagnosis of emphysema with CT evidence of hyperinflation . Absence of collateral ventilation according to Chartis Assessment System

You may not qualify if:

• Active pulmonary infection

Sponsors & Collaborators

• Pulmonx International Sàrl: lead

Study Sites (1)

Heidelberg Hospital

Heidelberg, D-69126, Germany

Location

MeSH Terms

Conditions

Pulmonary Emphysema; Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Felix JF Herth, Prof. Dr.

  Medizinische Fakultät Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 18, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 26, 2017

Record last verified: 2017-12

Locations

DE (1)