Clinical trial NCT03318406: Post-Market BTVA Registry
Official title: Post-Market Registry for Patients With Emphysema Treated With BTVA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emphysema or COPD
Keywords: registry
vapor ablation
InterVapor
BTVA
Lead sponsor: Uptake Medical Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with upper lobe predominant emphysema being evaluated for possible InterVapor treatment will be considered for enrollment in the Registry

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.

Detailed description: The BTVA Registry will enroll up to 300 patients with upper lobe predominant emphysema that are being treated with BTVA at sites located in the EU and other select geographies. Patients will be followed as per standard of care and the registry will collect follow-up data for five years following treatment. The follow up data collected will include pulmonary function measurements (spirometry, body plethysmography, and diffusing capacity for carbon monoxide), exercise capacity (six minute walk test), imaging findings (chest x-ray and CT), and a quality of life questionnaire (SGRQ-C). All serious and non-serious adverse events will also be collected for the duration of the study in order to assess safety. Serious adverse events will be adjudicated by an independent medical monitor in order to establish relatedness to the InterVapor device and procedure.

Descriptive statistics will be used to summarize all safety and effectiveness data. There is no predefined hypothesis regarding the magnitude of effectiveness of InterVapor or the incidence of specific safety outcomes.

Monitoring of the registry study will be undertaken as a continuous process to ensure that high-quality data are obtained and to ensure compliance with registry procedures.

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 -

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Serious Adverse Events
timeFrame: 6 and 12 months
measure: Change in FEV1
timeFrame: Baseline to 12 months
measure: Change in FVC
timeFrame: Baseline to 12 months
measure: Change in TLC
timeFrame: Baseline to 12 months
measure: Change in RV
timeFrame: Baseline to 12 months
measure: Change in DLCO
timeFrame: Baseline to 12 months
measure: Exercise Tolerance
timeFrame: Baseline to 12 months
measure: Lung volume reduction
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Krankenhaus Nord - Klinik Floridsdorf
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinikum am Bruderwald
city: Berlin
country: Germany
facility: DRK Kliniken Berlin / Mitte
city: Berlin
country: Germany
facility: FORSCHUNGSINSTITUT Havelhöhe gGmbH
city: Essen
country: Germany
facility: Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
city: Gauting
country: Germany
facility: Asklepios Fachkliniken München-Gauting
city: Halle
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg (Saale)
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: München
country: Germany
facility: Krankenhaus Martha-Maria München
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord
city: Stuttgart
country: Germany
facility: Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
city: Stuttgart
country: Germany
facility: Klinik Schillerhöhe
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Lungen-und Schlafzentrum am Lindenhofspital AG, Bern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Zürich
country: Switzerland
facility: LungenZentrum Hirslanden
city: Zürich
country: Switzerland
facility: Universitäts Spital Zürich
Study officials:
affiliation: Thoraxklinik University of Heidelberg
name: Felix Herth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: