Airway Bypass - Safety and Feasibility Study

NCT06249529 | Recruiting Early Phase 1

• 1 other identifier: CL2001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; Emphysema

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  including but not limited to device-related blood vessel perforation, pneumothorax, COPD exacerbation, device migration, device removal, rehospitalization.

  12 Months

Secondary Outcomes (7)

• Implant Success

  0 Days

• Procedural success

  1 Days

• CAT

  12 Months

• FEV1

  12 Months

• Residual Volume

  12 Months

Study Arms (1)

Interventional

EXPERIMENTAL

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

Device: Airway Bypass

Interventions

Airway Bypass DEVICE

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

Interventional

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, as confirmed 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 regular physical activity.

You may not qualify if:

• 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 450 meters in 6 minutes.
• Patient has evidence of any other disease that may compromise survival such as lung cancer, 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.

Sponsors & Collaborators

• Zoar Engelman: lead

Study Sites (1)

Israeli-Georgian Medical Research Clinic Healthycore

Tbilisi, Georgia

RECRUITING

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CSO

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: February 8, 2024
• Study Start: January 26, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

GE (1)