Airway Bypass - Safety and Feasibility Study

NCT ID: NCT06249529

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-26
• Study Completion Date: 2026-06-01

Brief 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.

Conditions

Emphysema or COPD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

Patients in the interventional arm will receive implant of one or more airway bypass devices.

Group Type: EXPERIMENTAL

Airway Bypass

Intervention Type: DEVICE

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

Interventions

Airway Bypass

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zoar Engelman

INDUSTRY

Sponsor Role: lead

Responsible Party

Zoar Engelman

CSO

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Israeli-Georgian Medical Research Clinic Healthycore

Tbilisi, , Georgia

Site Status: RECRUITING

Countries

Georgia

Facility Contacts

Tornike Jashi, MD

Role: primary

jashitornike@gmail.com

995595919096

Other Identifiers

CL2001

Identifier Type: -

Identifier Source: org_study_id