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Emphysema or COPDEarly Phase 1AIRWAYNCT06249529

Airway Bypass - Safety and Feasibility Study

A Early Phase 1 study testing Airway Bypass in people with Emphysema or COPD, run by Zoar Engelman at 1 site in Georgia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Emphysema or COPD
What is being tested?
Airway Bypass
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteGeorgia
Study dates
26 Jan 2024to 1 Jun 2026
Phase
Early Phase 1
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patient has clinically significant sputum production.
  • Patient has a change in FEV1 >20% post-bronchodilator.
  • Patient has a history of recurrent clinically significant respiratory infection, defined as with more than 3 hospital stays in the past 12 months.
  • Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure >50mmHg and/or evidenced by echocardiogram.
  • Patient has an inability to walk less than 140 meters (150 yards) or greater than 450 meters in 6 minutes.
  • Patient has evidence of any other disease that may compromise survival such as lung cancer, renal failure, any other investigator identified diseases.
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  • Patient has an inability to tolerate bronchoscopy under anesthesia.
  • Any contraindication to bronchoscopy procedure, including but not limited to:
  • Untreatable life-threatening arrhythmias
  • Inability to adequately oxygenate the patient during the procedure
  • Acute respiratory failure with hypercapnia
  • Myocardial infarction within 6 months
  • Previously diagnosed high-grade tracheal obstruction
  • Uncorrectable coagulopathy
  • Patient has clinically significant bronchiectasis.
  • Patient has giant bullae >1/3 lung volume.
  • Patient has had previous LVR surgery, lung transplant or lobectomy, or still has ELVR devices or other device to treat COPD in either lung.
  • Patient has been involved in other clinical studies within 30 days prior to this study.
  • Patient is taking >20mg prednisone (or similar steroid) daily.
  • Patient on antiplatelet agent (e.g., clopidogrel) or anticoagulant therapy (e.g., heparin or coumadin) or has not been weaned off prior to procedure.
  • Patient has any other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes.
  • A known allergy to nitinol.
  • Patient with uncontrolled diabetes as well as overweight patient (BMI >35 kg/m2).
  • Cancer needing chemotherapy in the past two years.
  • Patient with pleural effusion and/or pneumothorax.
  • Patient with a disease history of asthma, cystic fibrosis, interstitial lung disease (ILD), active tuberculosis.
  • 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.
  • Subject has severe gas exchange abnormalities as defined by: PaCO2 >55 mmHg, PaO2 <45 mmHg on room air.
  • Patient with acute ischemic heart disease, with proven pulmonary hypertension (SPAP >45 mmHg) in echocardiography and/or need for double platelet aggregation inhibition.

Trial locations and contacts

1 site in 1 country.

Georgia1 site, 1 recruiting

  • Israeli-Georgian Medical Research Clinic Healthycore

    Tbilisi

    Tornike Jashi, MD, 995595919096, jashitornike@gmail.com

    David Tchkonia, MD

    Recruiting

Other trials in Georgia

About this study

Official title: 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.

Being tested
Airway Bypass
Keywords
COPD, Emphysema
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.

  • Airway BypassDevice

    Bypass stent(s) are implanted to allow air trapped in the parenchyma to escape

Study groups in NCT06249529
Study groupRoleWhat they receive
InterventionalExperimentalPatients in the interventional arm will receive implant of one or more airway bypass devices.
Receives: Device: Airway Bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    including but not limited to device-related blood vessel perforation, pneumothorax, COPD exacerbation, device migration, device removal, rehospitalization.

    Measured: 12 Months

Secondary outcomes (7)

  1. Implant Success

    Device success, defined as the successful creation of the fenestration(s) and successful delivery of the stent(s) at the intended target position(s).

    Measured: 0 Days

  2. Procedural success

    Procedural success, defined as no occurrence of device-related or procedure-related SAEs during the hospital stay.

    Measured: 1 Days

  3. CAT

    Improvement of the COPD Assessment Test (CAT) score from baseline.

    Measured: 12 Months

  4. FEV1

    Improvement in forced expiratory volume in 1 second (FEV1) from baseline

    Measured: 12 Months

  5. Residual Volume

    Decrease in the Residual Volume (RV) from baseline

    Measured: 12 Months

  6. 6MWT

    Improvement in the 6-minute walk test from baseline

    Measured: 12 Months

  7. Dyspnea scale

    Improvement in the mMRC dyspnea scale from baseline

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start26 Jan 2024
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06249529
Sponsor's protocol ID
CL2001
Acronym
AIRWAY
Status last verified
Feb 2024
First submitted
15 Nov 2023
Last updated
8 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Airway Bypass in people with Emphysema or COPD, run by Zoar Engelman at 1 site in Georgia.

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 10 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 8 Feb 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 Georgia. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06249529.

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 8 Feb 2024.

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