Post-Market Registry for Patients with Emphysema Treated with BTVA
Research type
Research Study
Full title
InterVapor - Post-Market Registry for Patients with Emphysema Treated with BTVA
IRAS ID
236761
Contact name
Mohammed Munavvar
Contact email
Sponsor organisation
Uptake Medical Technology
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
Chronic obstructive pulmonary disease (COPD) is a prevalent, a preventable and treatable disease. It is characterized by progressive airflow limitation that is not fully reversible by inhaled medications. The abnormalities are a result of a mixture of small airways disease and long-standing lung tissue destruction.This causes reduction in lung elastic recoil, airflow limitation, air-trapping and hyperinflation.
The hyperinflation leads to progressive breathlessness with physical activity and decreased quality of life. As the disease progresses, increased frequency and severity of exacerbations are expected. Ultimately, the disease results in disability and premature mortality.
The InterVapor system is a minimally invasive bronchoscopic treatment that ablates the most diseased hyper-inflated lung. The device delivers heated water vapor through a bronchoscope channel to target areas of damaged lungs. This results in a reduction in damaged lung tissue and decrease in lung volume in patients with severe COPD. This reduction in lung volume allows healthy lung to work more efficiently and has resulted in clinical improvement and patients' quality of life.
This method of treatment has a few benefits over other current available procedures.
The InterVapor system received CE Mark approval for the treatment of patients with heterogeneous emphysema. This post-market registry will collect baseline and follo ow data from this patient population to establish the long term impact of InterVapor treatment on patient quality of life as well as confirm the shorter term (<1 year) safety and effectiveness profile in a real-work setting. With exception of a quality of life questionnaire, all procedures and evaluations during the study duration will be dictated by the standard of care.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0020
Date of REC Opinion
14 Feb 2018
REC opinion
Further Information Favourable Opinion