Mind The Gap - Crossing Borders Study

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Hyperinflation Lung; Emphysema; COPD

Treatments: Device: Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04256408

Mind The Gap

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Treatment group

Experimental group

Description:

Treatment group

Treatment:

Device: Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal