Airway Bypass - Safety and Feasibility Study (AIRWAY)

February 7, 2024 updated by: Zoar Engelman

Airway Bypass System - Safety and Feasibility Study A SINGLE-CENTER, PROSPECTIVE, SINGLE ARM STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF THE AIRWAY BYPASS SYSTEM

The objective of this study is to evaluate its safety and feasibility of the Airway Bypass Stent System in patients with severe emphysema. The study will collect clinical data through 12 months to assess procedural and device safety.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

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

  • Georgia
      • Tbilisi, Georgia
        • Recruiting
        • Israeli-Georgian Medical Research Clinic Healthycore
        • Contact:
        • Principal Investigator:
          • David Tchkonia, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient between 50 to 80 years old.
  2. High Resolution CT scan indicates severe emphysema.
  3. Patient has post- bronchodilator FEV1 less than or equal to 50% of predicted.
  4. Total Lung Capacity >100% of predicted.
  5. Residual volume ≥225 % of predicted.
  6. RV/TLC >0.69
  7. Patient has marked dyspnea scoring >2 on mMRC scale of 0-4.
  8. Patient has stopped smoking for a minimum of 8 weeks prior to entering the study, as confirmed by COHb ≤2.5%.
  9. Patient read, understood, and signed the Informed Consent form.
  10. Subject has completed a pulmonary rehab within the last year and/or performs regular physical activity.

Exclusion Criteria:

  1. Patient has clinically significant sputum production.
  2. Patient has a change in FEV1 >20% post-bronchodilator.
  3. Patient has a history of recurrent clinically significant respiratory infection, defined as with more than 3 hospital stays in the past 12 months.
  4. Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure >50mmHg and/or evidenced by echocardiogram.
  5. Patient has an inability to walk less than 140 meters (150 yards) or greater than 450 meters in 6 minutes.
  6. Patient has evidence of any other disease that may compromise survival such as lung cancer, renal failure, any other investigator identified diseases.
  7. Patient has an inability to tolerate bronchoscopy under anesthesia.

  8. Any contraindication to bronchoscopy procedure, including but not limited to:

    1. Untreatable life-threatening arrhythmias
    2. Inability to adequately oxygenate the patient during the procedure
    3. Acute respiratory failure with hypercapnia
    4. Myocardial infarction within 6 months
    5. Previously diagnosed high-grade tracheal obstruction
    6. Uncorrectable coagulopathy
  9. Patient has clinically significant bronchiectasis.
  10. Patient has giant bullae >1/3 lung volume.
  11. Patient has had previous LVR surgery, lung transplant or lobectomy, or still has ELVR devices or other device to treat COPD in either lung.
  12. Patient has been involved in other clinical studies within 30 days prior to this study.
  13. Patient is taking >20mg prednisone (or similar steroid) daily.
  14. Patient on antiplatelet agent (e.g., clopidogrel) or anticoagulant therapy (e.g., heparin or coumadin) or has not been weaned off prior to procedure.
  15. Patient has any other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes.
  16. A known allergy to nitinol.
  17. Patient with uncontrolled diabetes as well as overweight patient (BMI >35 kg/m2).
  18. Cancer needing chemotherapy in the past two years.
  19. Patient with pleural effusion and/or pneumothorax.
  20. Patient with a disease history of asthma, cystic fibrosis, interstitial lung disease (ILD), active tuberculosis.
  21. Patient with exacerbation of chronic obstructive pulmonary disease (COPD) within the last year which defined as: An acute event with the need of antibiotic treatment or hospitalization.
  22. Subject has severe gas exchange abnormalities as defined by: PaCO2 >55 mmHg, PaO2 <45 mmHg on room air.
  23. Patient with acute ischemic heart disease, with proven pulmonary hypertension (SPAP >45 mmHg) in echocardiography and/or need for double platelet aggregation inhibition.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Interventional
Patients in the interventional arm will receive implant of one or more airway bypass devices.
Device: Airway Bypass
Bypass stent(s) are implanted to allow air trapped in the parenchyma to escape

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 12 Months
including but not limited to device-related blood vessel perforation, pneumothorax, COPD exacerbation, device migration, device removal, rehospitalization.
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Implant Success
Time Frame: 0 Days
Device success, defined as the successful creation of the fenestration(s) and successful delivery of the stent(s) at the intended target position(s).
0 Days
Procedural success
Time Frame: 1 Days
Procedural success, defined as no occurrence of device-related or procedure-related SAEs during the hospital stay.
1 Days
CAT
Time Frame: 12 Months
Improvement of the COPD Assessment Test (CAT) score from baseline.
12 Months
FEV1
Time Frame: 12 Months
Improvement in forced expiratory volume in 1 second (FEV1) from baseline
12 Months
Residual Volume
Time Frame: 12 Months
Decrease in the Residual Volume (RV) from baseline
12 Months
6MWT
Time Frame: 12 Months
Improvement in the 6-minute walk test from baseline
12 Months
Dyspnea scale
Time Frame: 12 Months
Improvement in the mMRC dyspnea scale from baseline
12 Months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zoar Engelman

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL2001

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.

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