RecruitingEarly Phase 1NCT06249529

Airway Bypass - Safety and Feasibility Study

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


Sponsor

Zoar Engelman

Enrollment

10 participants

Start Date

Jan 26, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and feasibility of a bronchoscopic procedure that creates tiny bypass channels in the lung airways to help air escape more easily in people with severe emphysema (a lung disease where air becomes trapped, making breathing very difficult). The procedure is done through a tube passed into the lungs — no surgery required. **You may be eligible if...** - You are between 50 and 80 years old - You have severe emphysema confirmed on a CT scan - You have significant breathing difficulty (breathlessness rated above 2 out of 4) - Your lung function tests show severe airflow obstruction and air trapping - You have stopped smoking for at least 8 weeks - You have completed pulmonary rehab in the past year or exercise regularly **You may NOT be eligible if...** - You have significant mucus production or frequent coughs - Your breathing can improve greatly with a bronchodilator (inhalers) - You have had recent lung infections or major health events - You are currently smoking Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAirway Bypass

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


Locations(1)

Israeli-Georgian Medical Research Clinic Healthycore

Tbilisi, Georgia

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NCT06249529


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