Last updated: February 7, 2024
Sponsor: Zoar Engelman
Overall Status: Active - Recruiting
Phase
1
Condition
Emphysema
Treatment
Airway Bypass
Clinical Study ID
NCT06249529
CL2001
Ages 50-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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
- 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, asconfirmed 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 regularphysical activity.
Exclusion
Exclusion Criteria:
- 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 450meters in 6 minutes.
- Patient has evidence of any other disease that may compromise survival such as lungcancer, renal failure, any other investigator identified diseases.
- 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 ELVRdevices or other device to treat COPD in either lung.
- Patient has been involved in other clinical studies within 30 days prior to thisstudy.
- 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 upassessments 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 thelast year which defined as: An acute event with the need of antibiotic treatment orhospitalization.
- Subject has severe gas exchange abnormalities as defined by: PaCO2 >55 mmHg, PaO2 <45mmHg 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.
Study Design
Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Airway Bypass
Phase: 1
Study Start date:
January 26, 2024
Estimated Completion Date:
June 01, 2026
Connect with a study center
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi,
GeorgiaActive - Recruiting
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