- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04256408
Mind The Gap - Crossing Borders Study
Bronchoscopic Conversion of Collateral Ventilation in CV-positive Emphysema Patients Before Endobronchial Valve Treatment - Mind The Gap Crossing Borders Study
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:
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:
- To investigate the safety of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
- To investigate the effectiveness of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Groningen, Netherlands, 9700RB
- University Medical Center Groningen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of emphysema with a treatable target for endobronchial valves (Zephyr).
- Subjects of both genders of at least 35 years of age at the time of the baseline visit.
- Understand and voluntarily sign a patient informed consent form.
- 15 % predicted ≤ FEV1 ≤ 50% predicted.
- RV ≥ 175% predicted, and TLC ≥ 100% predicted and RV/TLC ≥ 55%.
- 6MWD ≥ 140 meters.
- Dyspnea score of ≥2 on the mMRC scale of 0-4.
- Non-smoker > 6 months prior to signing the informed consent.
- Chartis CV positive between target and ipsilateral lobe
Exclusion Criteria:
- Evidence of active pulmonary infection.
- Evidence of clinically significant bronchiectasis.
- History of more than 3 exacerbations with hospitalizations over the past 12 months.
- Myocardial infarction or other relevant cardiovascular events in the past 6 months.
- Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy.
- Prior endoscopic lung volume reduction.
- Unstable pulmonary nodule requiring follow-up
- Pregnant of nursing women.
- Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 < 6.0kPa, both measured on room air.
- Any disease with high probability of mortality within 24 months.
- Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins), which cannot be stopped periprocedural.
Patient was involved in other pulmonary drug studies within 30 days prior to this study.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Treatment group
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Transbronchial or transparenchymal injection of AeriSeal into the interlobar collateral ventilation channels region to convert CV-positive lobes into CV-negative lobes.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
feasibility - Target Lobar Volume Change on Chest -CT scan
Time Frame: 3 months
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To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety - Number and specification of reported (S)AEs per individual patient and as aggregate
Time Frame: 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.
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3 months
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changes in Quality of Life as measured by the SGRQ
Time Frame: 3 months
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By measuring the absolute change in The St George's Respiratory Questionnaire total score (0-100 points with higher scores indicating poor QOL)
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3 months
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effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).
Time Frame: 3 months
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By measuring changes in relative% in FEV1(L)
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3 months
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effectiveness - Measurement of change in Residual Volume (RV)
Time Frame: 3 months
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By measuring the change in absolute mL in RV
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3 months
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effectiveness - Measurement of changes in 6-minute walk test (6MWT)
Time Frame: 3 months
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By measuring the absolute change in meters in the 6MWT
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3 months
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changes in Quality of Life as measured by the COPD Assessment Test (CAT)
Time Frame: 3 months
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By measuring the absolute change in CAT score (0-40, with higher score indicating poor QOL)
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3 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Karin Klooster, PhD, UMC-Groningen/NL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIND THE GAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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