Primary safety objective: The primary safety objective of the study is to assess the safety of the Apreo Endobronchial System for treatment of severe emphysema.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of the rate of occurrence of serious adverse events (SAE) related to
the device and/or study procedure through 6 months post-Apreo Procedure #1.
Secondary outcome
Feasibility endpoints include: • Evaluation of ability to deploy the Apreo
Implant in target airways • Evaluate operator device use challenges •
Evaluation of operator understanding of instructions for use Preliminary
efficacy endpoints include: • Implant obstruction assessed bronchoscopically in
the proximal, medial and distal thirds at 3- and 6--month visits using a
semi-quantitative scale (0-5) with 0 representing no narrowing within the lumen
of the implant, 1: 1% - 10%, 2: >10% - 25%, 3: >25% - 50%, 4: >50% - 75%, 5:
>75% - 100%. • Mucous within the Apreo Implant assessed bronchoscopically in
the proximal, medial and distal thirds at 3- and 6--month visits using a
semi-quantitative scale with 0: No mucous within the lumen of the implant, 1:
Minimal, 2: Mild, 3: Moderate, 4: Severe, 5: Copious. • CT assessment of Apreo
Implant diameter in mm at the middle of the implant, 5 mm proximal to the
distal end and 5 mm distal to the proximal end at 6- and 12-month visits •
Change in the following at 1-3 days, 30 days, and 3, 6, and 12 months
post-Apreo Procedure #1 relative to baseline: o FEV1 o RV assessed by pulmonary
function testing o RV/TLC o FVC o FEV1/FVC o Exercise capacity (6MWD) o SGRQ-C
Score o CAT Score o mBORG Scores o mMRC Score • Change in DLCO at 6 months
post-Apreo Procedure #1 relative to baseline • Change in RV assessed by
quantitative CT analysis at 6 and 12 months post-Apreo Procedure #1 relative to
baseline • ABG parameters: PaO2 and PaCO2 at 6 months post-Apreo Procedure #1
relative to baseline Secondary Safety Endpoints • Percentage of participants
with acute procedural complications (within 24 hours of an Apreo Procedure •
Rates of occurrence of serious adverse events (SAE) related to the device
and/or Apreo Procedure through 24 months post-Apreo Procedure #1 • Rates of
adverse device effects through 24 months post-Apreo Procedure #1
Background summary
Emphysema is a lung condition that causes shortness of breath. In people with
emphysema, the air sacs in the lungs (alveoli) are damaged. Over time, the
inner walls of the air sacs weaken and rupture, creating larger air spaces
instead of many small spaces. This larger air space reduces the air sac wall
elasticity and reduces the amount of oxygen that reaches the bloodstream. When
you exhale, the damaged alveoli do not work properly and old air becomes
trapped, leaving no room for fresh, oxygen-rich air to enter. The trapped air
can cause the lungs to overinflate (hyperinflation).
The Apreo Endobronchial System is made up of the Apreo Implant and Apreo
Delivery System.
The Apreo Implant is an investigational implant that is a metal tube that acts
like a scaffold to hold open your airways in your lungs, and the Apreo Delivery
System is an investigational catheter that is used to place the Apreo Implant
in the lung airway.
Study objective
Primary safety objective: The primary safety objective of the study is to
assess the safety of the Apreo Endobronchial System for treatment of severe
emphysema.
Study design
First-in-human, prospective, multi-center, single-arm study
Intervention
Implantation of the Apreo Endobronchial Implant into the affected lung(s).
Study burden and risks
Subjects will be required to visit the hospital for the procedures and
follow-up visits, where they will complete questionnaires and undergo tests
(listed in detail in the previous part of this form) multiple times during the
study. The procedure(s) will require 1-3 days hospitalization.
There are potential risks associated with the Apreo Endobronchial System, as
listed in section 2.3.4 of the protocol. There may also be risks that are
unanticipated at this time. The Apreo Endobronchial System was designed to
minimize unacceptable and/or unnecessary risk. While some residual risks
remain, these residual risks are considered acceptable when accounting for the
potential benefits of increasing pulmonary function, exercise capacity, and
quality of life for patients who suffer from severe emphysema.
The protocol is designed to minimize risk to potential participants through
careful selection of appropriate participants, robust study procedures,
follow-up and ongoing safety surveillance. Based on the risk analysis and risk
minimization strategies described above, the potential risks to participants
are outweighed by the potential benefits.
4040 Campbell Ave 110
Menlo Park, CA CA 94025
US
4040 Campbell Ave 110
Menlo Park, CA CA 94025
US
Listed location countries
Age
Inclusion criteria
1. Age >= 35 and <= 80 years old 2. Computed tomography (CT) scan evidence of
homogeneous or heterogeneous emphysema 3. At least one target lobe with > 35%
destruction (percent of voxels with < -950 Hounsfield units on CT) 4.
Post-bronchodilator ratio of FEV1/FVC < 0.7 at screening 5. Post-bronchodilator
FEV1 percent predicted >=15% and <=50% of predicted at screening 6.
Post-bronchodilator RV > 180% predicted 7. Post-bronchodilator RV/TLC >= 0.55 at
screening 8. Marked dyspnea, scoring >= 2 on the modified Medical Research
Council scale of 0-4 9. 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 10. Fully vaccinated
for Covid-19 and has current pneumococcus and influenza vaccination (or
documented clinical intolerance) 11. Cognitively and physically able to provide
written informed consent and complete participant questionnaires
Exclusion criteria
1. Arterial blood PaCO2 > 60 mmHg (8 kPa) or PaO2 <= 45 mmHg (6 kPa) 2. DCLO
<20% at screening 3. Steroid therapy of 10 mg prednisolone (prednisone) or more
per day 4. Three or more acute exacerbations of COPD in the past year before
enrollment 5. Two or more hospitalizations for acute exacerbations of COPD or
respiratory infections in the past year before enrollment 6. Any acute
exacerbation of COPD or respiratory infection less than 4 weeks before the
first Apreo Procedure 7. Previous lung volume reduction surgery or lobectomy,
segmentectomy or bullectomy, vapor, glue, or other pulmonary device implant 8.
Known history of pulmonary arterial hypertension 9. Presence of a giant bulla
(>= 30% of hemithorax) 10. History of excessive dynamic airway collapse of the
trachea or main bronchi 11. History of adult asthma or chronic bronchitis 12.
Presence of suspicious pulmonary nodule/infiltrate that requires additional
follow-up, diagnostics or treatment 13. Unequivocal and symptomatic
bronchiectasis 14. Unequivocal lung cancer or other current cancer diagnosis
except non-metastasized basal cell skin cancer 15. 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 16. Uncorrectable coagulopathy or other condition likely to
increase risk of peri- or post- Apreo Procedure bleeding 17. On anticoagulant
or antiplatelet therapy and unable or unwilling to hold for Apreo Procedure 18.
Coronary artery disease with angina 19. History of myocardial infarction within
6 months 20. History of a stroke less than 1 year before the first Apreo
Procedure 21. Clinical history of heart failure with documented LVEF <= 40% 22.
Clinical history of diabetes with a HbA1c > 9.0% 23. Estimated glomerular
filtration rate (eGFR) <30 mL/min/1.73m2 (CKD-EPI) OR participant with kidney
failure (Stage 5 kidney disease)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ClinicalTrials.gov Identifier: NCT05854550 |
| CCMO | NL84373.000.23 |