No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
300 (estimated)
Sponsor
Uptake Medical Technology, Inc. · Industry
Who this trial is looking for
This trial is looking for patients with a specific type of emphysema to participate in a registry. Participants will receive treatment and be followed for 5 years to see how it affects their quality of life and lung function.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with heterogeneous emphysema
I am at least 18 years old
I can provide informed consent
You may not be able to join if
My lung function (FEV1) is below 20% of what is expected
My lung diffusion capacity (DLCO) is below 20% of what is expected
I cannot walk more than 140 meters in 6 minutes
I have been hospitalized for COPD and needed antibiotics more than 3 times in the past 12 months
I have been hospitalized for COPD in the past 3 months
I use systemic steroids daily
I have a significant health condition that increases my risk of complications
I am currently pregnant or breastfeeding
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Bronchoscopic thermal vapor ablation using Uptake Medical Technology Inc.'s InterVapor System is indicated for treatment of patients with heterogeneous upper lobe emphysema. This study is a retrospective and prospective, observational, multi-center, post-market registry of patients prescribed InterVapor. The primary objective of the Registry is to describe the long-term impact of InterVapor treatm…
Bronchoscopic thermal vapor ablation using Uptake Medical Technology Inc.'s InterVapor System is indicated for treatment of patients with heterogeneous upper lobe emphysema. This study is a retrospective and prospective, observational, multi-center, post-market registry of patients prescribed InterVapor. The primary objective of the Registry is to describe the long-term impact of InterVapor treatment on patient quality of life (QOL) in a real-world setting. After InterVapor treatment, patients will be followed for 5 years as per the standard of care and safety and efficacy data (quality of life, pulmonary function, exercise capacity) collected as part of the registry.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patients will have heterogeneous emphysema, as evidenced by high-resolution computed tomography (HRCT) demonstrating a heterogeneity index \> or equal to 1.2 in at least one segment to be treated
2. Patients must be \> or equal to 18 years of age
3. Patients are required to p…
Inclusion Criteria:
1. Patients will have heterogeneous emphysema, as evidenced by high-resolution computed tomography (HRCT) demonstrating a heterogeneity index \> or equal to 1.2 in at least one segment to be treated
2. Patients must be \> or equal to 18 years of age
3. Patients are required to provide informed consent prior to inclusion in the Registry
Exclusion Criteria:
1. FEV1 \< 20% predicted
2. DLCO \< 20% predicted
3. Inability to walk \> 140 meters in 6 minutes (6MWD) following optimized medical management
4. Unstable COPD (any of the following):
1. \> 3 COPD related hospitalizations requiring antibiotics in past 12 months
2. COPD related hospitalization in past 3 months
3. daily use of systemic steroids, i.e. \> 5 mg prednisolone
5. 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, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency
6. Newly prescribed morphine derivatives within the last 4 weeks
7. Pregnant or breastfeeding
8. Highly diseased lower lobes (tissue to air ratio of \<11%)
9. Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)
10. Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe
11. Recent respiratory infections or COPD exacerbation in preceding 6 weeks -
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