Post-Market Registry for Patients With Emphysema Treated With BTVA

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Krankenhaus Nord - Klinik Floridsdorf
RECRUITING
Vienna
Germany
Sozialstiftung Bamberg, Klinikum am Bruderwald
RECRUITING
Bamberg
DRK Kliniken Berlin / Mitte
RECRUITING
Berlin
FORSCHUNGSINSTITUT Havelhöhe gGmbH
RECRUITING
Berlin
Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
RECRUITING
Essen
Asklepios Fachkliniken München-Gauting
RECRUITING
Gauting
Martin-Luther-Universität Halle-Wittenberg (Saale)
RECRUITING
Halle
Thoraxklinik Heidelberg
RECRUITING
Heidelberg
Lungenklinik Hemer
RECRUITING
Hemer
Lungenfachklinik Immenhausen
RECRUITING
Immenhausen
Krankenhaus Martha-Maria München
NOT_YET_RECRUITING
München
Klinikum Nürnberg Nord
RECRUITING
Nuremberg
Klinik Schillerhöhe
RECRUITING
Stuttgart
Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
RECRUITING
Stuttgart
Switzerland
Kantonsspital Aarau AG
RECRUITING
Aarau
University Hospital Basel
NOT_YET_RECRUITING
Basel
Lungen-und Schlafzentrum am Lindenhofspital AG, Bern
RECRUITING
Bern
Kantonsspital St.Gallen
WITHDRAWN
Sankt Gallen
LungenZentrum Hirslanden
RECRUITING
Zurich
Universitäts Spital Zürich
RECRUITING
Zurich
Contact Information
Primary
Jennifer Idris
jidris@broncus.com
+1-408-391-0098
Time Frame
Start Date: 2018-03-22
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 300
Treatments
BTVA treated patients
Patients with heterogeneous upper lobe emphysema undergoing Bronchoscopic Thermal Vapor Ablation treatment
Sponsors
Leads: Uptake Medical Technology, Inc.

This content was sourced from clinicaltrials.gov