Mind The Gap - Crossing Borders Study

Not Applicable

Completed

• Conditions: Emphysema; COPD; Hyperinflation Lung
• Interventions: Device: Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal

• Registration Number: NCT04256408
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Study Start: 2021-06-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal	Treatment group

Primary Outcome Measures

Name	Time	Method
feasibility - Target Lobar Volume Change on Chest -CT scan	3 months	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 Outcome Measures

Name	Time	Method
effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).	3 months	By measuring changes in relative% in FEV1(L)
effectiveness - Measurement of change in Residual Volume (RV)	3 months	By measuring the change in absolute mL in RV
safety - Number and specification of reported (S)AEs per individual patient and as aggregate	3 months	To investigate the safety of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. Thsi by collection of all adverse events, and specifically: death, pnuemothorax, pneumonia, COPD exacerbation, and post treatment inflammatory response.
changes in Quality of Life as measured by the SGRQ	3 months	By measuring the absolute change in The St George's Respiratory Questionnaire total score (0-100 points with higher scores indicating poor QOL)
effectiveness - Measurement of changes in 6-minute walk test (6MWT)	3 months	By measuring the absolute change in meters in the 6MWT
changes in Quality of Life as measured by the COPD Assessment Test (CAT)	3 months	By measuring the absolute change in CAT score (0-40, with higher score indicating poor QOL)

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands