BridgeMD
New treatment option for Severe Emphysema
Official title A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema
ClinicalTrials.gov ID: NCT06152107
What this study is testing
- What it's testing
- To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age≥18 years old;
- Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT;
- Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study;
- 15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%);
- 6MWD \>140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test)
You likely can't join if
- Contraindications to bronchoscopy, such as: Prior myocardial infarction within 1 month, unstable myocardial ischaemia, ejection fraction (EF) ≤ 40%...
- Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of...
- Use of morphine derivatives within 4 weeks prior to screening;
- Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit;
- Recent COPD exacerbation in preceding 6 weeks;
- Severe emphysema in both the upper and lower lobes of the contralateral lungs, defined as %LAA-950 assessed by HRCT as a percentage of whole lung...
See the full eligibility criteria
- Age≥18 years old;
- Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT;
- Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study;
- 15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%);
- 6MWD \>140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test)
- mMRC score≥2;
- Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2\>50 mmHg on room air;
- Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment.
- Contraindications to bronchoscopy, such as: Prior myocardial infarction within 1 month, unstable myocardial ischaemia, ejection fraction (EF) ≤ 40%; Active haemoptysis; Coagulation disorders; Malignant cardiac...
- Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include: immune system disorders...
- Use of morphine derivatives within 4 weeks prior to screening;
- Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit;
- Recent COPD exacerbation in preceding 6 weeks;
- Severe emphysema in both the upper and lower lobes of the contralateral lungs, defined as %LAA-950 assessed by HRCT as a percentage of whole lung lobe volume \> 40%;
- Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe;
- Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.);
- History of heart and/or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, thoracic surgery with removal of lung tissue and endobronchial lung volume reduction (via valves, coils...
- Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist;
- Pregnant or breastfeeding;
- Current enrollment in any other investigational study which has not completed requisite follow-up;
- Any conditions assessed by investigator that make patients inappropriate for enrolment.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Beijing, China
- Chengdu, China
- Linyi, China
- Nanchang, China
- Shanghai, China
- Shijiazhuang, China
- Zhejiang, China
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China; Beijing, China; Chengdu, China; Linyi, China; Nanchang, China; Shanghai, China and 2 more location(s). 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.