Post-Market BTVA Registry

NCT03318406 | Recruiting

• 1 other identifier: CSP-2410
• Study Type: observational
• Target: 300
• Locations: 3 countries
• Sites: 20

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.

Conditions

Emphysema or COPD

Keywords

registry; vapor ablation; InterVapor; BTVA

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life

  Change in Quality of Life score as assessed by the SGRQ-C questionnaire

  Baseline to 24 months

Secondary Outcomes (8)

• Serious Adverse Events

  6 and 12 months

• Change in FEV1

  Baseline to 12 months

• Change in FVC

  Baseline to 12 months

• Change in TLC

  Baseline to 12 months

• Change in RV

  Baseline to 12 months

Study Arms (1)

BTVA treated patients

Patients with heterogeneous upper lobe emphysema undergoing Bronchoscopic Thermal Vapor Ablation treatment

Device: Bronchoscopic Thermal Vapor Ablation

Interventions

Bronchoscopic Thermal Vapor Ablation DEVICE

Bronchoscopic vapor delivery to airway segment(s) targeted for treatment

Also known as: BTVA, InterVapor

BTVA treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• FEV1 \< 20% predicted
• DLCO \< 20% predicted
• Inability to walk \> 140 meters in 6 minutes (6MWD) following optimized medical management
• Unstable COPD (any of the following):
• \> 3 COPD related hospitalizations requiring antibiotics in past 12 months
• COPD related hospitalization in past 3 months
• daily use of systemic steroids, i.e. \> 5 mg prednisolone
• 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
• Newly prescribed morphine derivatives within the last 4 weeks
• Pregnant or breastfeeding
• Highly diseased lower lobes (tissue to air ratio of \<11%)
• Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)
• Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe
• Recent respiratory infections or COPD exacerbation in preceding 6 weeks -

Sponsors & Collaborators

• Uptake Medical Technology, Inc.: lead

Study Sites (20)

Krankenhaus Nord - Klinik Floridsdorf

Vienna, 1210, Austria

RECRUITING

Sozialstiftung Bamberg, Klinikum am Bruderwald

Bamberg, 96049, Germany

RECRUITING

DRK Kliniken Berlin / Mitte

Berlin, 13359, Germany

RECRUITING

FORSCHUNGSINSTITUT Havelhöhe gGmbH

Berlin, 14089, Germany

RECRUITING

Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45147, Germany

RECRUITING

Asklepios Fachkliniken München-Gauting

Gauting, 82131, Germany

RECRUITING

Martin-Luther-Universität Halle-Wittenberg (Saale)

Halle, 06120, Germany

RECRUITING

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

RECRUITING

Lungenklinik Hemer

Hemer, 58675, Germany

RECRUITING

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

RECRUITING

Krankenhaus Martha-Maria München

München, 81479, Germany

NOT YET RECRUITING

Klinikum Nürnberg Nord

Nuremberg, 90419, Germany

RECRUITING

Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH

Stuttgart, 70372, Germany

RECRUITING

Klinik Schillerhöhe

Stuttgart, 70376, Germany

RECRUITING

Kantonsspital Aarau AG

Aarau, 5001, Switzerland

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

NOT YET RECRUITING

Lungen-und Schlafzentrum am Lindenhofspital AG, Bern

Bern, 3012, Switzerland

RECRUITING

Kantonsspital St.Gallen

Sankt Gallen, 9000, Switzerland

WITHDRAWN

LungenZentrum Hirslanden

Zurich, 8032, Switzerland

RECRUITING

Universitäts Spital Zürich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Felix Herth, MD, PhD

  Thoraxklinik University of Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Idris

CONTACT

+1-408-391-0098; jidris@broncus.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 23, 2017
• Study Start: March 22, 2018
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (13); AU (1); CH (6)