Mind The Gap

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

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-08-31

Brief Summary

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Rationale: A big step forward and great opportunity to improve overall efficacy of bronchoscopic lung volume reductioen is to combine treatment modalities aiming to close the dependent collateral channels and then proceed with EBV therapy to induce lobar collapse, and thus maximal treatment effect.

Objective:

Primary objective:

1. To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.

Secondary objectives:
2. To investigate the safety of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
3. To investigate the effectiveness of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.

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Detailed Description

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Conditions

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Emphysema COPD Hyperinflation Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Group Type EXPERIMENTAL

Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal

Intervention Type DEVICE

Transbronchial or transparenchymal injection of AeriSeal into the interlobar collateral ventilation channels region to convert CV-positive lobes into CV-negative lobes.

Interventions

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Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal

Transbronchial or transparenchymal injection of AeriSeal into the interlobar collateral ventilation channels region to convert CV-positive lobes into CV-negative lobes.

Intervention Type DEVICE

Other Intervention Names

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Aeriseal

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of emphysema with a treatable target for endobronchial valves (Zephyr).
2. Subjects of both genders of at least 35 years of age at the time of the baseline visit.
3. Understand and voluntarily sign a patient informed consent form.
4. 15 % predicted ≤ FEV1 ≤ 50% predicted.
5. RV ≥ 175% predicted, and TLC ≥ 100% predicted and RV/TLC ≥ 55%.
6. 6MWD ≥ 140 meters.
7. Dyspnea score of ≥2 on the mMRC scale of 0-4.
8. Non-smoker \> 6 months prior to signing the informed consent.
9. Chartis CV positive between target and ipsilateral lobe

Exclusion Criteria

1. Evidence of active pulmonary infection.
2. Evidence of clinically significant bronchiectasis.
3. History of more than 3 exacerbations with hospitalizations over the past 12 months.
4. Myocardial infarction or other relevant cardiovascular events in the past 6 months.
5. Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy.
6. Prior endoscopic lung volume reduction.
7. Unstable pulmonary nodule requiring follow-up
8. Pregnant of nursing women.
9. Hypercapnia defined by PaCO2 \> 8.0kPa, or Hypoxemia defined by PaO2 \< 6.0kPa, both measured on room air.
10. Any disease with high probability of mortality within 24 months.
11. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins), which cannot be stopped periprocedural.
12. Patient was involved in other pulmonary drug studies within 30 days prior to this study.

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Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No