| NCT ID | NCT03318406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uptake Medical Technology, Inc. |
| Condition | Emphysema or COPD |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2018-03-22 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2018-03-22 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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 -
Contact & Investigator
Felix Herth, MD, PhD
PRINCIPAL INVESTIGATOR
Heidelberg University
Frequently Asked Questions
Who can join the NCT03318406 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Emphysema or COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03318406 currently recruiting?
Yes, NCT03318406 is actively recruiting participants. Contact the research team at jidris@broncus.com for enrollment information.
Where is the NCT03318406 trial being conducted?
This trial is being conducted at Vienna, Austria, Bamberg, Germany, Berlin, Germany, Berlin, Germany and 11 additional locations.
Who is sponsoring the NCT03318406 clinical trial?
NCT03318406 is sponsored by Uptake Medical Technology, Inc.. The principal investigator is Felix Herth, MD, PhD at Heidelberg University. The trial plans to enroll 300 participants.
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