EmphysemaNCT04256408
Mind The Gap - Crossing Borders Study
A study testing Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal in people with Emphysema and COPD, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Emphysema, COPD, Hyperinflation Lung
- What is being tested?
- Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
- Conditions
- Emphysema, COPD, Hyperinflation Lung
- Being tested
- Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic transparenchymal interlobar fissure closure using AerisealDevice
Also called Aeriseal
Transbronchial or transparenchymal injection of AeriSeal into the interlobar collateral ventilation channels region to convert CV-positive lobes into CV-negative lobes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Treatment group Receives: Device: Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (6)
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.
Measured: 3 months
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)
Measured: 3 months
effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).
By measuring changes in relative% in FEV1(L)
Measured: 3 months
effectiveness - Measurement of change in Residual Volume (RV)
By measuring the change in absolute mL in RV
Measured: 3 months
effectiveness - Measurement of changes in 6-minute walk test (6MWT)
By measuring the absolute change in meters in the 6MWT
Measured: 3 months
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jun 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Pulmonx Corporation
- Responsible party
- Principal investigator, Dirk-Jan Slebos, University Medical Center Groningen
- Investigators
- Karin Klooster, PhD, Study director, UMC-Groningen/NL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256408
- Sponsor's protocol ID
- Mind The Gap
- Status last verified
- Jul 2024
- First submitted
- 20 Jan 2020
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Conversion of Collateral Ventilation in CV-positive Emphysema Patients Before Endobronchial Valve Treatment - Mind The Gap Crossing Borders Study
- ClinicalTrials.gov ID
- NCT04256408
- Acronym / sponsor ID
- Mind The Gap
- Conditions
- Emphysema, COPD, Hyperinflation Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Pulmonx Corporation
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Bronchoscopic transparenchymal interlobar fissure closure using AerisealTreatment group |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopic transparenchymal interlobar fissure closure using AerisealAlso: AerisealTransbronchial or transparenchymal injection of AeriSeal into the interlobar collateral ventilation channels region to convert CV-positive lobes into CV-negative lobes. | Device | Treatment group |
Primary outcome
feasibility - Target Lobar Volume Change on Chest -CT scan
Time frame: 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
6 secondary outcomes
safety - Number and specification of reported (S)AEs per individual patient and as aggregate
Time frame: 3 months
changes in Quality of Life as measured by the SGRQ
Time frame: 3 months
effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).
Time frame: 3 months
effectiveness - Measurement of change in Residual Volume (RV)
Time frame: 3 months
effectiveness - Measurement of changes in 6-minute walk test (6MWT)
Time frame: 3 months
changes in Quality of Life as measured by the COPD Assessment Test (CAT)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Klooster, PhD study director
UMC-Groningen/NL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal in people with Emphysema and COPD, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility - Target Lobar Volume Change on Chest -CT scan (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.