Clinical trial for Emphysema or COPD
Official title A Multi Center Study Testing a New Implant for Adults With Severe Emphysema
ClinicalTrials.gov ID: NCT07119229
What this study is testing
- What it's testing
- The study aims to see how well the implant works and how safe it is for people with severe emphysema or COPD.
- Who it's for
- Adults who have severe emphysema or COPD.
- What's involved
- Participants will receive the implant and attend scheduled visits and tests to monitor their health.
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 between 100-meters and 400-meters at baseline exam.
You likely can't join if
- 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 (\ 50% of predicted value at screening. 18. PaCO2 \> 50 mm Hg at screening. 19.
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 between 100-meters and 400-meters at baseline exam.
- Stable disease with less than 10-mg prednisone (or equivalent) daily
- Non-smoking for 4-months prior to screening interview (including tobacco, vaping, marijuana, etc.).
- FEV1 between 15% and 50% of predicted value at baseline exam.
- FEV1/FVC \<70%.
- Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation \<-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 (\< -950HU) as determined by CT core lab.
- RV \> 175% of predicted value.
- mMRC score ≥ 2.
- 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 (\ 50% of predicted value at screening. 18. PaCO2 \> 50 mm Hg at screening. 19.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Milwaukee, Wisconsin, United States
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, but 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?
This study is enrolling now at San Francisco, California, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Milwaukee, Wisconsin, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.