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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04559464




Registration number
NCT04559464
Ethics application status
Date submitted
16/09/2020
Date registered
22/09/2020
Date last updated
28/06/2024

Titles & IDs
Public title
Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status (CONVERT)
Scientific title
Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema; A Multicenter, Prospective Trial
Secondary ID [1] 0 0
630-0030-01
Universal Trial Number (UTN)
Trial acronym
CONVERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emphysema 0 0
COPD 0 0
Severe Emphysema 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - AeriSeal
Treatment: Devices - Zephyr Valves

Other: AeriSeal and Zephyr Valve Treatment - Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System (conversion of the CV+ target lobe to CV-).

Stage 2 will include successfully converted subjects in Stage 1. Converted CV- target lobes will follow standard of care and receive the Zephyr Endobronchial valves per the Zephyr Instructions for Use (IFU) to perform bronchoscopic lung volume reduction (BLVR).


Treatment: Devices: AeriSeal
The AeriSeal Foam functions by blocking both small airways and collateral channels causing absorption atelectasis in the treated region of the lung. Occlusion with the foam also yields a targeted fibrotic response which durably reduces lung hyperinflation. The reduction in hyperinflation allows the healthier parts of the lung to re-inflate and improve breathing mechanics and gas exchange. In this study, the AeriSeal delivery will be limited to three segments that contain the collateral channel(s) between lung lobes. A minimum 10 mL volume of AeriSeal will be delivered per segment, with a total delivered volume limit of 40 mL per subject (including re-treatment, if needed) in a total of three segments.

Treatment: Devices: Zephyr Valves
The Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of subjects converted from a positive collateral ventilation status (CV+) to having little to no collateral ventilation (CV-) in the treated lobe.
Timepoint [1] 0 0
6-weeks post-AeriSeal treatment
Primary outcome [2] 0 0
Treated Lobe Volume Reduction (TLVR) responders
Timepoint [2] 0 0
45-days post-Zephyr Valve treatment
Secondary outcome [1] 0 0
Forced Expiratory Volume in 1 second (FEV1)
Timepoint [1] 0 0
3-months
Secondary outcome [2] 0 0
Residual volume (RV)
Timepoint [2] 0 0
3-months

Eligibility
Key inclusion criteria
1. Subject is willing and able to provide Informed Consent and to participate in the study.
2. Subject is = 40 and = 75 years of age at the time Informed Consent signature.
3. Subject has at least one lobe with = 50% emphysema destruction (at -910 HU) as determined by QCT.
4. Subject has a diagnosis of homogenous or heterogeneous emphysema, confirmed by HRCT scan. Heterogeneous emphysema defined as = 15% difference (at -910 HU) in emphysema destruction score of adjacent lobes by HRCT.
5. Subject has a gap in the interlobar fissure that corresponds to one or more segments as determined by QCT.
6. Subject has clinically significant dyspnea with a mMRC Dyspnea score = 2.
7. Subject has a Six-Minute Walk Distance = 250 meters.
8. Subject has post-bronchodilator FEV1 = 15% predicted and = 50% predicted.
9. Subject has post-bronchodilator Total Lung Capacity = 100% predicted.
10. Subject has post-bronchodilator Residual Volume = 150% predicted if heterogeneous emphysema and = 200% predicted if homogeneous emphysema.
11. Subject has stopped smoking for at least eight (8) weeks prior to Screening visit as confirmed by carboxyhemoglobin or cotinine levels.
12. Subject has received preventive vaccinations against potential respiratory infections consistent with local recommendations or policy.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has severe bullous emphysema where bulla is = 1/3 of the total lung volume.
2. Subject has had prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior ipsilateral pleurodesis, or prior endobronchial lung volume reduction therapy of any type.
3. Subject has evidence of active respiratory infection.
4. Subject has an ongoing COPD exacerbation or bronchospasm.
5. Subject has a known allergy to the device components:

1. Polyether block amide - PEBAX®
2. Polyvinyl Alcohol
3. Glutaraldehyde
4. Nitinol (nickel-titanium) or its constituent metals (nickel or titanium)
5. Silicone
6. Subject requires invasive ventilatory support (NOTE: The use of continuous Positive Airway Pressure (CPAP) and BiPAP devices for Sleep Apnea is permitted).
7. Subject has post-bronchodilator Diffusion Capacity (DLCO) < 20% predicted.
8. Subject cannot tolerate corticosteroids or relevant antibiotics.
9. Subject has other relevant comorbidities as judged by the Investigator or is deconditioned and cannot tolerate the stress of post-treatment inflammatory response.
10. Subject has had three (3) or more COPD exacerbations requiring hospitalization during the year prior to Informed Consent signature.
11. Subject has severe gas exchange abnormalities as defined by any one of the following (test conducted at rest on room air as tolerated, or on up to 4 L/min supplemental O2):

1. PaCO2 = 55 mm Hg (7.3 kPa)
2. PaO2 < 45 mm Hg (6.0 kPa)
3. SpO2 < 90%
12. Subject has uncontrolled pulmonary hypertension, defined as peak pulmonary systolic pressure > 45 mm Hg on echocardiogram or right heart catheterization.
13. Subject use of systemic steroids > 20 mg/day prednisolone or equivalent within 4 weeks of Informed Consent signature.
14. Subject use of immunosuppressive agents within four (4) weeks of Informed Consent signature.
15. Subject whose use heparins and oral anticoagulants (e.g., warfarin, dicumarol) cannot be discontinued according to local pre-procedural protocols. Note: antiplatelet drugs including aspirin and clopidogrel are permitted.
16. Subject's CT scan indicates the presence of any the following radiologic abnormalities:

1. Pulmonary nodule on CT scan greater than 0.8 cm in diameter (Does not apply if present for one (1) year or more without increase in size or if proven benign by biopsy).
2. Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate.
3. Significant interstitial lung disease.
4. Significant pleural disease.
17. Subject's baseline EKG indicates non-atrial arrhythmias or conduction abnormalities.
18. Subject has high cardiac risk after undergoing cardiac risk assessment in accordance with published guidelines or ischemic heart disease, congestive heart failure, renal failure, or cerebrovascular disease.
19. Subject has clinically significant asthma (reversible airway obstruction), chronic bronchitis, or bronchiectasis.
20. Subject has allergy or sensitivity to medications required to safely perform bronchoscopy under conscious sedation or general anesthesia.
21. Subject participated in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to Screening visit. Subjects being followed as part of a long-term surveillance of a non-pulmonary study that has reached its primary endpoint are eligible for participation in this study.
22. Subject has Body Mass Index (BMI) < 18 kg/m2 or > 35 kg/m2.
23. Subject is a female who is pregnant, breast-feeding, or planning to be pregnant in next 12 months.
24. Subject has clinically significant abnormal screening laboratory test results per the Institution specific reference laboratory normal values for the following:

1. White blood cells (total)
2. Hematocrit
3. Platelets
4. Prothrombin time or INR
5. Partial thromboplastin time
6. Positive ß-HCG Pregnancy test (if female)
25. Subject has evidence of severe disease which in the judgment of the Investigator may compromise survival for the duration of the study (at least 12 months) e.g.:

1. HIV/AIDs
2. Active malignancy
3. Stroke or Transient Ischemic attack (TIA) within 12 months of Screening visit
4. Myocardial infarction within six (6) months of the Screening visit
5. Congestive heart failure within six (6) months of the Screening visit defined as clinical evidence of right or left heart failure or left ventricular ejection fraction < 45% on echocardiogram
26. Subject has uncontrolled diabetes mellitus.
27. Subject has any other condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject including but not limited to alcoholism, high risk for drug abuse, or noncompliance in returning for follow-up visits.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Wesley Hospital - Brisbane
Recruitment hospital [2] 0 0
Macquarie University Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Limoges
Country [2] 0 0
France
State/province [2] 0 0
Toulouse
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Germany
State/province [4] 0 0
Essen
Country [5] 0 0
Germany
State/province [5] 0 0
Heidelberg
Country [6] 0 0
Italy
State/province [6] 0 0
Brescia
Country [7] 0 0
Netherlands
State/province [7] 0 0
Groningen
Country [8] 0 0
Switzerland
State/province [8] 0 0
Rämistrasse 100
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Scotland
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Cardiff
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pulmonx Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 20 investigational sites. The Study plans to enroll up to 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System to occlude collateral air channels in a target lung lobe with collateral ventilation (CV) and convert the target lung lobe to having little to no collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study will have two Stages:

• Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted, provided that the total application volume from both the initial and the repeat treatments does not exceed 40 mL in up to three (3) segments.

Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment and repeated after the second treatment, if applicable. For the purpose of protocol follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2.

• Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1. Converted CV- target lobes will follow standard of care and receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction (BLVR).

Clinical assessments will be conducted at 45 Days, 3-months, 6-months, and 12-months post-Zephyr Valve procedure.
Trial website
https://clinicaltrials.gov/study/NCT04559464
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joshua Percy
Address 0 0
Pulmonx Corporation
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