STEP-UP
Research type
Research Study
Full title
Sequential Segmental Treatment of Emphysema with Upper Lobe Predominance Trial (STEP-UP): A randomised controlled trial of InterVapor
IRAS ID
133104
Contact name
Pallav Shah
Contact email
Sponsor organisation
Uptake Medical
Clinicaltrials.gov Identifier
Research summary
Emphysema is a serious illness that affects millions of people worldwide. As the disease gets worse, it leads to increasing breathlessness, decreased quality of life and can result in death. In emphysema the narrowed airways in the lungs prevent a patient breathing out fully. The lungs become enlarged and full of holes. As a result the lungs have too much air trapped inside them which makes it difficult to breathe. Medications, oxygen and rehabilitation help improve symptoms but do not cure the disease. One approach to deal with this is to shrink the damaged lung (lung volume reduction) and provide more room for healthier lung to breathe and open up the airways.
The InterVapor system is a minimally invasive treatment designed for lung volume reduction. A small, flexible camera (bronchoscope) is passed through the mouth into the lungs. The most diseased part of the lung is treated with steam which causes a gradual shrinking of that part over several weeks resulting in lung volume reduction.
This is an international, multicentre randomised controlled trial investigating the effectiveness and safety of bronchoscopic thermal vapor ablation (InterVapor) in patients with severe, upper lobe emphysema. 10 patients will be recruited in the United Kingdom. Patients will be randomly allocated to one of two groups. Two thirds will receive treatment with InterVapor and one third will be the control group who will continue to receive their normal medical treatment only. The final assessment of response to treatment will be at 1 year. Improvement in lung function and health related quality of life will be the primary outcome but exercise capacity and safety will also be measured.
If successful, then Intervapor may provide a treatment for patients with emphysema who might otherwise have limited treatment options.
REC name
London - Stanmore Research Ethics Committee
REC reference
13/LO/1385
Date of REC Opinion
1 Nov 2013
REC opinion
Further Information Favourable Opinion