First in Human Study to Assess an Implant to Treat Severe Emphysema

NCT05854550 | Completed DMC

• 1 other identifier: CIP-0001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants. The main questions it aims to answer are: Is it safe? Does it work? Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed in each lung during the procedure(s). Participants will be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the procedure(s).

Conditions

Emphysema or COPD

Keywords

hyperinflation; air-trapping; emphysema; COPD

Outcome Measures

Primary Outcomes (1)

• Rate of Serious Adverse Events (SAE) at 6 Months

  Rate of occurrence of serious adverse events related to the study device and/or study procedure through 6 months post-study procedure

  6 Months

Secondary Outcomes (71)

• Device Evaluation: Device Deployment Assessment

  During Procedure

• Device Evaluation: Device Usability Survey

  During Procedure

• Device Evaluation: Instructions for Use (IFU) Survey

  During Procedure

• Efficacy Evaluation: Airway Patency at 30 Days

  30 Days

• Efficacy Evaluation: Airway Patency at 3 Months

  3 Months

Study Arms (1)

Apreo Implant Group

EXPERIMENTAL

This group will undergo up to 2 procedures and will receive up to 3 implants during in each lung.

Device: Apreo Implant Group

Interventions

Apreo Implant Group DEVICE

One or two procedures involving placement of up to three Apreo implants in the bronchial tree of each lung.

Apreo Implant Group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 35 and ≤ 80 years old
• Computed tomography (CT) scan evidence of homogeneous or heterogeneous emphysema
• At least one target lobe with \> 35% destruction (percent of voxels with \< -950 Hounsfield units on CT)
• Post-bronchodilator ratio of FEV1/FVC \< 0.7 at screening
• Post-bronchodilator FEV1 percent predicted ≥20% and ≤50% of predicted at screening
• Post-bronchodilator RV \> 180% predicted
• Post-bronchodilator RV/TLC ≥ 0.55 at screening
• Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4
• Cotinine testing at screening indicates nonsmoker and stopped smoking at least 8 weeks before entering the trial and agrees to refrain from smoking for duration of study participation
• Participation in a pulmonary rehabilitation program and/or confirmed to have been engaged or attempted regular physical activity in the 12 months prior to the first Apreo Procedure and agrees to continue or restart regular physical activity for the duration of the study
• Fully vaccinated for Covid-19 (up to date per Australian Government Guidelines) and has current pneumococcus and influenza vaccination (or documented clinical intolerance)
• Cognitively and physically able to provide written informed consent and complete participant questionnaires

You may not qualify if:

• Arterial blood PaCO2 \> 60 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa)
• DLCO \<20% at screening
• Steroid therapy of 10 mg prednisolone (prednisone) or more per day
• Three or more acute exacerbations of COPD in the past year before enrollment
• Two or more hospitalizations for acute exacerbations of COPD or respiratory infections in the past year before enrollment
• Any acute exacerbation of COPD or respiratory infection less than 4 weeks before the first Apreo Procedure
• Previous lung volume reduction surgery or lobectomy, segmentectomy or bullectomy, vapor, glue, or other pulmonary device implant
• Known history of pulmonary arterial hypertension
• Presence of a giant bulla (≥ 30% of hemithorax)
• History of excessive dynamic airway collapse of the trachea or main bronchi
• History of adult asthma or chronic bronchitis
• Presence of suspicious pulmonary nodule/infiltrate that requires additional follow-up, diagnostics or treatment
• Unequivocal and symptomatic bronchiectasis
• Unequivocal lung cancer or other current cancer diagnosis except non-metastasized basal cell skin cancer
• Uncontrolled hypertension (blood pressure that is inadequately treated or resistant to treatment) with a systolic \> 200 mmHg or diastolic \> 110 mmHg at screening or prior to first Apreo Procedure

Sponsors & Collaborators

• Apreo Health, Inc.: lead

Study Sites (2)

Macquarie University Hospital

Macquarie, New South Wales, 2109, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

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: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 11, 2023
• Study Start: May 5, 2023
• Primary Completion: October 8, 2024
• Study Completion: February 16, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)