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The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.

NCT ID: NCT05396131

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-20

Study Completion Date

2022-01-07

Brief Summary

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The aim of this study is to determine the feasibility of combining a lung sealant with endobronchial valves EBV in managing patients with COPD who are collateral ventilation (CV) positive. This study has two arms; arm 1 is for CV positive participants who will receive the lung sealant and EBV; arm 2 is the CV negative group who will only receive EBV as the standard management.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants diagnosed as either Collateral Ventilation (CV) Negative or CV Positive.

CV Negative participants will only receive the endobronchial valves (EBV). CV Positive participants will receive both the lung sealant and the EBV.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Collateral Ventilation Negative

Collateral Ventilation Negative participants will have endobronchial valve implant

Group Type ACTIVE_COMPARATOR

Endobronchial Valve (EBV)

Intervention Type DEVICE

The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.

Collateral Ventilation Positive

Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant

Group Type EXPERIMENTAL

Lung Sealant

Intervention Type DEVICE

The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction.

Endobronchial Valve (EBV)

Intervention Type DEVICE

The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.

Interventions

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Lung Sealant

The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction.

Intervention Type DEVICE

Endobronchial Valve (EBV)

The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.

Intervention Type DEVICE

Other Intervention Names

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AeriSeal Zephyr Endobronchial Valve System

Eligibility Criteria

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Inclusion Criteria

* i. 18-85 years of age
* ii. Forced Expiratory Volume in 1second (FEV1) 20 - 50%
* iii. Residual Volume (RV) \> 175%
* iv. 6 min walk test \> 150 m
* v. Completed a course of Pulmonary rehabilitation
* vi. STRATX assessment - Left Upper Lobe as the most appropriate lobe to target for ELVR
* vii. This study will be investigating heterogenous emphysema only. Minimum of 15% differential in emphysema destruction scores at -950 HU

Exclusion Criteria

* i. Acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment
* ii. Acute respiratory tract infections
* iii. Significant bronchiectasis,
* iv. Co-existing interstitial lung diseases, pneumothorax,
* v. Known active malignancy
* vi. Pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Macquarie University, Australia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alvin J Ing, MBBS, MD, FRACP

Role: PRINCIPAL_INVESTIGATOR

Clinical Professor and Respiratory Physician

Locations

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Macquarie University

Macquarie Park, New South Wales, Australia

Site Status

Countries

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Australia

References

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Ing AJ, Jayapadman A, Kim WV, Ly C, Ho-Shon K, Lilburn P, Carew A, Ng BJH, Saghaie T, Williamson JP. Reversal of collateral ventilation using endoscopic polymer foam in COPD patients undergoing endoscopic lung volume reduction with endobronchial valves: A controlled parallel group trial. Respirology. 2022 Dec;27(12):1064-1072. doi: 10.1111/resp.14338. Epub 2022 Aug 2.

Reference Type DERIVED
PMID: 35918295 (View on PubMed)

Other Identifiers

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AI-MCVP-COPD-ELVR

Identifier Type: -

Identifier Source: org_study_id