Clinical trial NCT06249529: Airway Bypass - Safety and Feasibility 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Emphysema or COPD
Keywords: COPD
Emphysema
Lead sponsor: Deerfield Catalyst
Sponsor class: INDUSTRY
First posted: 2024-02-08
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Adverse Events
timeFrame: 12 Months
Secondary outcomes:
measure: Implant Success
timeFrame: 0 Days
measure: Procedural success
timeFrame: 1 Days
measure: CAT
timeFrame: 12 Months
measure: FEV1
timeFrame: 12 Months
measure: Residual Volume
timeFrame: 12 Months
measure: 6MWT
timeFrame: 12 Months
measure: Dyspnea scale
timeFrame: 12 Months
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Israeli-Georgian Medical Research Clinic Healthycore
Study officials:
References: