Mind The Gap - Crossing Borders Study

NCT04256408 | Completed

• 1 other identifier: Mind The Gap
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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. 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.
2. 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. 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.

Conditions

Emphysema; COPD; Hyperinflation Lung

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• safety - Number and specification of reported (S)AEs per individual patient and as aggregate

  3 months

• changes in Quality of Life as measured by the SGRQ

  3 months

• effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).

  3 months

• effectiveness - Measurement of change in Residual Volume (RV)

  3 months

• effectiveness - Measurement of changes in 6-minute walk test (6MWT)

  3 months

Study Arms (1)

Treatment group

EXPERIMENTAL

Treatment group

Device: Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal

Interventions

Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal DEVICE

Transbronchial or transparenchymal injection of AeriSeal into the interlobar collateral ventilation channels region to convert CV-positive lobes into CV-negative lobes.

Also known as: Aeriseal

Treatment group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• % predicted ≤ FEV1 ≤ 50% predicted.
• RV ≥ 175% predicted, and TLC ≥ 100% predicted and RV/TLC ≥ 55%.
• MWD ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Pulmonx Corporation: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Karin Klooster, PhD

  UMC-Groningen/NL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. D.J. Slebos MD, PhD

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: February 5, 2020
• Study Start: June 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)