Post-Market BTVA Registry

Emphysema or COPD Clinical Trial

Official title:

Post-Market Registry for Patients With Emphysema Treated With BTVA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03318406
• Other study ID #: CSP-2410
• Status: Recruiting
• Start date: March 22, 2018
• Est. completion date: December 1, 2028

Study information

• Verified date: July 2023
• Source: Uptake Medical Technology, Inc.
• Contact: Jennifer Idris
• Phone: +1-408-391-0098
• Email: jidris[@]broncus.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2028
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Emphysema
• Emphysema or COPD
• Pulmonary Emphysema

Intervention

Device:
• Bronchoscopic Thermal Vapor Ablation
Bronchoscopic vapor delivery to airway segment(s) targeted for treatment

Locations

Country	Name	City	State
Austria	Krankenhaus Nord - Klinik Floridsdorf	Vienna
Germany	Sozialstiftung Bamberg, Klinikum am Bruderwald	Bamberg
Germany	DRK Kliniken Berlin / Mitte	Berlin
Germany	FORSCHUNGSINSTITUT Havelhöhe gGmbH	Berlin
Germany	Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH	Essen
Germany	Asklepios Fachkliniken München-Gauting	Gauting
Germany	Martin-Luther-Universität Halle-Wittenberg (Saale)	Halle
Germany	Thoraxklinik Heidelberg	Heidelberg
Germany	Lungenklinik Hemer	Hemer
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	Krankenhaus Martha-Maria München	München
Germany	Klinikum Nürnberg Nord	Nürnberg
Germany	Klinik Schillerhöhe	Stuttgart
Germany	Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH	Stuttgart
Switzerland	Kantonsspital Aarau AG	Aarau
Switzerland	University Hospital Basel	Basel
Switzerland	Lungen-und Schlafzentrum am Lindenhofspital AG, Bern	Bern
Switzerland	Kantonsspital St.Gallen	St. Gallen
Switzerland	LungenZentrum Hirslanden	Zürich
Switzerland	Universitäts Spital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Uptake Medical Technology, Inc.

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life	Change in Quality of Life score as assessed by the SGRQ-C questionnaire	Baseline to 24 months
Secondary	Serious Adverse Events	procedure and device related serious adverse events, major medical complications	6 and 12 months
Secondary	Change in FEV1	Change in Forced Expired Volume in 1 second	Baseline to 12 months
Secondary	Change in FVC	Change in Forced Vital Capacity	Baseline to 12 months
Secondary	Change in TLC	Change in Total Lung Capacity	Baseline to 12 months
Secondary	Change in RV	Change in Residual Volume	Baseline to 12 months
Secondary	Change in DLCO	Change in Diffusing capacity of the lung for carbon monoxide	Baseline to 12 months
Secondary	Exercise Tolerance	Change in six minute walk distance	Baseline to 12 months
Secondary	Lung volume reduction	change in lung volume assessed by CT	Baseline to 6 months