Mind The Gap - Crossing Borders Study

October 17, 2022 updated by: Dirk-Jan Slebos, University Medical Center Groningen

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:

  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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Groningen, Netherlands, 9700RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Treatment group
Transbronchial or transparenchymal injection of AeriSeal into the interlobar collateral ventilation channels region to convert CV-positive lobes into CV-negative lobes.
Other Names:
  • Aeriseal

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
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 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.
3 months
changes in Quality of Life as measured by the SGRQ
Time Frame: 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)
3 months
effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).
Time Frame: 3 months
By measuring changes in relative% in FEV1(L)
3 months
effectiveness - Measurement of change in Residual Volume (RV)
Time Frame: 3 months
By measuring the change in absolute mL in RV
3 months
effectiveness - Measurement of changes in 6-minute walk test (6MWT)
Time Frame: 3 months
By measuring the absolute change in meters in the 6MWT
3 months
changes in Quality of Life as measured by the COPD Assessment Test (CAT)
Time Frame: 3 months
By measuring the absolute change in CAT score (0-40, with higher score indicating poor QOL)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Karin Klooster, PhD, UMC-Groningen/NL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

January 2, 2023

Study Completion (Anticipated)

September 2, 2023

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Emphysema

3
Subscribe