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New treatment option for COPD
Official title A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema
ClinicalTrials.gov ID: NCT07086339
What this study is testing
- What it's testing
- A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Signed Informed Consent
- Diagnosis of COPD/emphysema
- At least 22-years of age
- 18 ≤ BMI ≤ 32
- 6-minute walk Distance of between 100 - and 400 meters
You likely can't join if
- Currently participating in another clinical study that involves surgery, treatment or pharmaceutical treatment
- α-1 Antitrypsin deficiency
- Women of child-bearing potential
- More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening
- Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention
- Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening
See the full eligibility criteria
- Signed Informed Consent
- Diagnosis of COPD/emphysema
- At least 22-years of age
- 18 ≤ BMI ≤ 32
- 6-minute walk Distance of between 100 - and 400 meters
- Stable disease with less than 10-mg prednisone (or equivalent) daily
- Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.).
- FEV1 between 15% and 45% of predicted value at baseline exam
- FEV1/FVC \<70%
- Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation less than -950 HU, as determined by CT core lab.
- Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score less than -950 HU, as determined by CT core lab.
- RV \> 175% of predicted value.
- mMRC score ≥ 2
- Currently participating in another clinical study that involves surgery, treatment or pharmaceutical treatment
- α-1 Antitrypsin deficiency
- Women of child-bearing potential
- More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening
- Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention
- Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening
- Clinically significant mucus production or chronic bronchitis
- Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening
- Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR)
- Clinically significant bronchiectasis
- Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days
- Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \>45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram
- Suspected malignant pulmonary nodule or other lung cancer
- HRCT collected per CT scanning protocol within the last 6 months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:
- Large bullae encompassing greater than 30% of either lung
- Insufficient landmarks to evaluate the CT study using the software as it is intended
- All lobes are less than 25% parenchyma diseased (\< -950 HU).
- Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
- TLC \< 100% predicted at screening
- DLCO \ 50% of predicted value at screening
- PaCO2 \> 50 mm Hg at screening
- PaO2 \< 45 mm Hg in room air at screening
- Plasma cotinine level \> 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) \>2.5% at screening.
- Current diagnosis of substance abuse disorder.
- Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder
- Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.
The study team makes the final eligibility decision.
Where it's taking place
- Limoges, France
- Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Limoges, France; Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.