Bronchoscopic Release of Air Trapped in Hyperinflated Emphysematous Lung

Apreo Health, Inc.3 sites in 3 countries30 target enrollmentAugust 15, 2023

ConditionsEmphysema or COPD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Emphysema or COPD
Sponsor: Apreo Health, Inc.
Enrollment: 30
Locations: 3
Primary Endpoint: Rate of Serious Adverse Events (SAE) at 6 Months
Status: Active, not recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants at up to 5 study centers located in Europe and the United Kingdom. The main questions this clinical trial aim 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).

Detailed Description

This is a first-in-human, prospective, multi-center, single-arm study assessing the safety, feasibility and preliminary efficacy of the Apreo Implant for severe emphysema in up to 30 participants. Initially all participants will undergo an Apreo Procedure involving placement of up to three implants in a native bronchial tree of one lung followed by a second Apreo Procedure 30 days later to place up to three implants in the contralateral native lung bronchial tree if indicated. Once the fifth participant has undergone his or her first implantation procedure, implantations in currently enrolled or new participants will be paused to allow for a Safety Review Committee (SRC) to convene and review safety data once the 5th participant has completed the 7-day phone follow-up after their second Apreo Procedure (or first if only one procedure). This would be at a minimum acute procedural safety for up to 10 implantation procedures conducted in these first 5 participants, 30-day safety assessments for all 5 participants after their first lung implantations, bronchoscopic inspection 30 days after implantation of all implants in the first lung, and 7-day safety data after their first and second lung implantations. The SRC will provide comments and recommendations, including the restart of implantation for new participants, if deemed appropriate. After the first 10 participants have completed the 7-day phone follow-up after the second Apreo Procedure (or first if only one procedure), their safety data will be reviewed by the SRC. This would include at a minimum acute procedural safety for up to 20 implantation procedures conducted in these first 10 participants, 30-day safety assessments for all 10 participants after their first lung implantations, bronchoscopic inspection 30 days after implantation of all implants in the first lung, and 7-day safety data after their first and second lung implantations. Following the review of the first 10 participants' safety data, the SRC may allow any subsequently enrolled participants to undergo one Apreo Procedure (rather than two separate procedures if appropriate for a participant) to deploy Apreo Implants in both the left and right lung airways as indicated or to continue to have all participants undergo two separate Apreo Procedures if indicated. A total of up to 30 participants will be enrolled overall. All participants will be followed at 30 days, three, six and twelve months post the first Apreo Procedure and assessments include adverse event (AE) assessment, pulmonary function testing, bronchoscopy, and quality of life assessments (Day 30, and 3, 6, and 12 months) and an inspiratory/expiratory chest CT at 6 and 12 months. A phone follow-up for AE assessment will occur at 7 days after each Apreo Procedure.

Registry

clinicaltrials.gov

Start Date

August 15, 2023

End Date

June 1, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Apreo Health, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 ≥15% 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 or carboxyhemoglobin 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

Exclusion Criteria

•Arterial blood on room air: PaCO2 \> 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa)
•DLCO \<20% at screening
•Steroid therapy of 10 mg prednisolone (prednisone) or more per day
•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 or suspected history of pulmonary arterial hypertension with a PASP \> 50 mmHg on echocardiogram or mPAP \> 25 mmHg on a right heart catheterization
•Presence of a giant bulla (≥ 30% of hemithorax)
•History of adult asthma or chronic bronchitis
•Presence of suspicious pulmonary nodule/infiltrate that requires additional follow-up, diagnostics or treatment

Outcomes

Primary Outcomes

Rate of Serious Adverse Events (SAE) at 6 Months

Time Frame: 6 Months

Rate of occurrence of serious adverse events related to the study device and/or study procedure through 6 months post-study procedure #1

Secondary Outcomes

Efficacy Evaluation: Mucus Assessment at 3 Months(3 Months)
Device Evaluation: Device Usability Survey(During Procedure)
Device Evaluation: Instructions for Use Survey(During Procedure)
Efficacy Evaluation: Mucus Assessment at 6 Months(6 Months)
Efficacy Evaluation: Computed Tomography (CT) Scan at 6 Months(6 Months)
Efficacy Evaluation: Residual Volume (RV) at 6 Months(6 Months)
Efficacy Evaluation: Residual Volume (RV) at 12 Months(12 Months)
Efficacy Evaluation: Arterial Blood Gas (ABG): PaO2 at 6 Months(6 Months)
Safety: Procedural Complications(Through 24 hours post-procedure)
Efficacy Evaluation: Forced Expiratory Volume at 1 Second/ Forced Vital Capacity (FEV1/FVC) at 3 Months(3 Months)
Efficacy Evaluation: Airway Patency at 3 Months(3 Months)
Efficacy Evaluation: Airway Patency at 6 Months(6 Months)
Efficacy Evaluation: Mucus Assessment at 30 Days(30 Days)
Efficacy Evaluation: Mucus Assessment at 12 Months(12 Months)
Efficacy Evaluation: Forced Expiratory Volume in 1 Second (FEV1) at 1-3 Days(1-3 Days)
Efficacy Evaluation: Forced Expiratory Volume in 1 Second (FEV1) at 6 Months(6 Months)
Efficacy Evaluation: Airway Patency at 12 Months(12 Months)
Device Evaluation: Device Deployment Assessment(During Procedure)
Efficacy Evaluation: Computed Tomography (CT) Scan at 12 Months(12 Months)
Efficacy Evaluation: Forced Expiratory Volume in 1 Second (FEV1) at 12 Months(12 Months)
Efficacy Evaluation: Forced Expiratory Volume at 1 Second/ Forced Vital Capacity (FEV1/FVC) at 1-3 Days(1-3 Days)
Efficacy Evaluation: Forced Expiratory Volume at 1 Second/ Forced Vital Capacity (FEV1/FVC) at 30 Days(30 Days)
Efficacy Evaluation: Forced Expiratory Volume at 1 Second/ Forced Vital Capacity (FEV1/FVC) at 6 Months(6 Months)
Efficacy Evaluation: Residual Volume/Total Lung Capacity (RV/TLC) at 30 Days(30 Days)
Efficacy Evaluation: Residual Volume/Total Lung Capacity (RV/TLC) at 3 Months(3 Months)
Efficacy Evaluation: Forced Vital Capacity (FVC) at 12 Months(12 Months)
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 3 Months(3 Months)
Efficacy Evaluation: Airway Patency at 30 Days(30 Days)
Efficacy Evaluation: Forced Expiratory Volume in 1 Second (FEV1) at 30 Days(30 Days)
Efficacy Evaluation: Forced Expiratory Volume in 1 Second (FEV1) at 3 Months(3 Months)
Efficacy Evaluation: Arterial Blood Gas (ABG): PaCO2 at 6 Months(6 Months)
Efficacy Evaluation: Residual Volume (RV) Assessed by Pulmonary Function Testing at 12 Months(12 Months)
Efficacy Evaluation: Residual Volume/Total Lung Capacity (RV/TLC) at 6 Months(6 Months)
Efficacy Evaluation: Residual Volume/Total Lung Capacity (RV/TLC) at 12 Months(12 Months)
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 30 Days(30 Days)
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 6 Months(6 Months)
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 12 Months(12 Months)
Efficacy Evaluation: COPD Assessment Test (CAT) at 1-3 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)(1-3 Days)
Safety: Rate of SAEs(Through 12 Months)
Safety: Rate of Adverse Device Effects(Through 12 Months)
Efficacy Evaluation: Residual Volume (RV) Assessed by Pulmonary Function Testing at 30 Days(30 Days)
Efficacy Evaluation: Residual Volume (RV) Assessed by Pulmonary Function Testing at 3 Months(3 Months)
Efficacy Evaluation: Residual Volume (RV) Assessed by Pulmonary Function Testing at 6 Months(6 Months)
Efficacy Evaluation: Forced Vital Capacity (FVC) at 3 Months(3 Months)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 3 Months(3 Months)
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 6 Months(6 Months)
Efficacy Evaluation: Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) at 6 Months(6 Months)
Efficacy Evaluation: Residual Volume (RV) Assessed by Pulmonary Function Testing at 1-3 Days(1-3 Days)
Efficacy Evaluation: Forced Vital Capacity (FVC) at 1-3 Days(1-3 Days)
Efficacy Evaluation: Forced Vital Capacity (FVC) at 30 Days(30 Days)
Efficacy Evaluation: Forced Vital Capacity (FVC) at 6 Months(6 Months)
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 1-3 Days(1-3 Days)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 30 Days(30 Days)
Efficacy Evaluation: COPD Assessment Test (CAT) at 3 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)(3 Months)
Efficacy Evaluation: COPD Assessment Test (CAT) at 6 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)(6 Months)
Efficacy Evaluation: COPD Assessment Test (CAT) at 12 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)(12 Months)
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 30 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)(30 Days)
Efficacy Evaluation: Forced Expiratory Volume at 1 Second/ Forced Vital Capacity (FEV1/FVC) at 12 Months(12 Months)
Efficacy Evaluation: Residual Volume/Total Lung Capacity (RV/TLC) at 1-3 Days(1-3 Days)
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 6 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)(6 Months)
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 1-3 Days(1-3 Days)
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 30 Days(30 Days)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 1-3 Days(1-3 Days)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 6 Months(6 Months)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 12 Months(12 Months)
Efficacy Evaluation: COPD Assessment Test (CAT) at 30 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)(30 Days)
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 1-3 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)(1-3 Days)
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 12 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)(12 Months)
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 12 Months(12 Months)
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 3 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)(3 Months)
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 3 Months(3 Months)