Actively Recruiting
Airway Bypass - Safety and Feasibility Study
Led by Zoar Engelman · Updated on 2024-02-08
10
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Airway Bypass - Safety and Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient between 50 to 80 years old.
- High Resolution CT scan indicates severe emphysema.
- Post-bronchodilator FEV1 less than or equal to 50% of predicted.
- Total Lung Capacity greater than 100% of predicted.
- Residual volume at least 225% of predicted.
- RV/TLC ratio greater than 0.69.
- Marked dyspnea with a score greater than 2 on the mMRC scale of 0-4.
- Stopped smoking for a minimum of 8 weeks prior to study entry, confirmed by COHb less than or equal to 2.5%.
- Read, understood, and signed the informed consent form.
- Completed pulmonary rehabilitation within the last year and/or performs regular physical activity.
You will not qualify if you...
- Clinically significant sputum production.
- Change in FEV1 greater than 20% post-bronchodilator.
- History of recurrent clinically significant respiratory infection with more than 3 hospital stays in the past 12 months.
- Uncontrolled pulmonary hypertension with right ventricular pressure greater than 50 mmHg or evidence by echocardiogram.
- Inability to walk less than 140 meters or more than 450 meters in 6 minutes.
- Evidence of other diseases that may compromise survival such as lung cancer, renal failure, or other investigator identified diseases.
- Inability to tolerate bronchoscopy under anesthesia.
- Contraindications to bronchoscopy including untreatable life-threatening arrhythmias, inability to oxygenate during the procedure, acute respiratory failure with hypercapnia, myocardial infarction within 6 months, high-grade tracheal obstruction, or uncorrectable coagulopathy.
- Clinically significant bronchiectasis.
- Giant bullae larger than one-third lung volume.
- Previous lung volume reduction surgery, lung transplant, lobectomy, or presence of ELVR devices or other COPD treatment devices.
- Participation in other clinical studies within 30 days prior.
- Taking more than 20 mg prednisone or similar steroid daily.
- Use of antiplatelet or anticoagulant therapy not weaned off prior to procedure.
- Other diseases interfering with study completion or outcomes.
- Known allergy to nitinol.
- Uncontrolled diabetes or body mass index over 35 kg/m2.
- Cancer requiring chemotherapy in the past two years.
- Presence of pleural effusion or pneumothorax.
- History of asthma, cystic fibrosis, interstitial lung disease, or active tuberculosis.
- COPD exacerbation within the last year requiring antibiotics or hospitalization.
- Severe gas exchange abnormalities with PaCO2 over 55 mmHg or PaO2 under 45 mmHg on room air.
- Acute ischemic heart disease, pulmonary hypertension with SPAP over 45 mmHg, or need for double platelet aggregation inhibition.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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