Airway Bypass - Safety and Feasibility Study (AIRWAY)

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: Recruiting
• Conditions: Emphysema or COPD
• Intervention / Treatment: Device: Airway Bypass

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Recruiting
    • Israeli-Georgian Medical Research Clinic HEALTHYCORE
    • Contact: Tornike Jashi, MD; Phone Number: 995595919096; Email: jashitornike@gmail.com
    • Principal Investigator: David Tchkonia, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Adverse Events	including but not limited to device-related blood vessel perforation, pneumothorax, COPD exacerbation, device migration, device removal, rehospitalization.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	0 Days
Procedural success	Procedural success, defined as no occurrence of device-related or procedure-related SAEs during the hospital stay.	1 Days
CAT	Improvement of the COPD Assessment Test (CAT) score from baseline.	12 Months
FEV1	Improvement in forced expiratory volume in 1 second (FEV1) from baseline	12 Months
Residual Volume	Decrease in the Residual Volume (RV) from baseline	12 Months
6MWT	Improvement in the 6-minute walk test from baseline	12 Months
Dyspnea scale	Improvement in the mMRC dyspnea scale from baseline	12 Months

Collaborators and Investigators

• Sponsor: Zoar Engelman

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Emphysema
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Pulmonary Emphysema; Emphysema
• Other Study ID 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