Post-Market BTVA Registry
ConditionEmphysema or COPD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUptake Medical Technology, Inc.
About this trial
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
Qualifiers
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
Patients must be > or equal to 18 years of age
Patients are required to provide informed consent prior to inclusion in the Registry
Disqualifiers
FEV1 < 20% predicted
DLCO < 20% predicted
Inability to walk > 140 meters in 6 minutes (6MWD) following optimized medical management
> 3 COPD related hospitalizations requiring antibiotics in past 12 months
Trial design
Treatments tested in this trial
- Bronchoscopic Thermal Vapor Ablation
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov