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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05396131




Registration number
NCT05396131
Ethics application status
Date submitted
20/09/2021
Date registered
31/05/2022
Date last updated
31/05/2022

Titles & IDs
Public title
The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.
Scientific title
The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR (Endoscopic Lung Volume Reduction) Utilizing Endobronchial Valves
Secondary ID [1] 0 0
AI-MCVP-COPD-ELVR
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Lung Sealant
Treatment: Devices - Endobronchial Valve (EBV)

Active comparator: Collateral Ventilation Negative - Collateral Ventilation Negative participants will have endobronchial valve implant

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


Treatment: Devices: 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.

Treatment: Devices: Endobronchial Valve (EBV)
The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-)
Timepoint [1] 0 0
4 weeks post lung sealant application
Secondary outcome [1] 0 0
Number of participants with improved lung functioning as measured by lung function tests
Timepoint [1] 0 0
12weeks and 52 weeks post valve implant
Secondary outcome [2] 0 0
Changes Lung volume
Timepoint [2] 0 0
12weeks and 52 weeks post valve implant

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/01/2022
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University - Macquarie Park
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Other
Name
Macquarie University, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05396131
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alvin J Ing, MBBS, MD, FRACP
Address 0 0
Clinical Professor and Respiratory Physician
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05396131