Mind The Gap - Crossing Borders Study

COPD Clinical Trial

Official title:

Bronchoscopic Conversion of Collateral Ventilation in CV-positive Emphysema Patients Before Endobronchial Valve Treatment - Mind The Gap Crossing Borders Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04256408
• Other study ID #: Mind The Gap
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: September 2, 2023

Study information

• Verified date: October 2022
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Est. completion date: September 2, 2023
• Est. primary completion date: January 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• COPD
• Emphysema
• Hyperinflation Lung
• Pulmonary Emphysema

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Pulmonx Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility - Target Lobar Volume Change on Chest -CT scan	To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment	3 months
Secondary	safety - Number and specification of reported (S)AEs per individual patient and as aggregate	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.	3 months
Secondary	changes in Quality of Life as measured by the SGRQ	By measuring the absolute change in The St George's Respiratory Questionnaire total score (0-100 points with higher scores indicating poor QOL)	3 months
Secondary	effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).	By measuring changes in relative% in FEV1(L)	3 months
Secondary	effectiveness - Measurement of change in Residual Volume (RV)	By measuring the change in absolute mL in RV	3 months
Secondary	effectiveness - Measurement of changes in 6-minute walk test (6MWT)	By measuring the absolute change in meters in the 6MWT	3 months
Secondary	changes in Quality of Life as measured by the COPD Assessment Test (CAT)	By measuring the absolute change in CAT score (0-40, with higher score indicating poor QOL)	3 months