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Mind The Gap - Crossing Borders Study

NCT04256408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-07-11

No results posted yet for this study

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.

Conditions

  • Emphysema
  • COPD
  • Hyperinflation Lung

Interventions

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.

Sponsors & Collaborators

  • Pulmonx Corporation

    collaborator INDUSTRY

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Karin Klooster, PhD · UMC-Groningen/NL

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04256408 on ClinicalTrials.gov