PneumRX registry
Research type
Research Study
Full title
CLN0014 Rev C All comers Post Marketing study collecting long term safety and effectiveness data on the use of RePneu coils for the treatment of severe emphysema
IRAS ID
181479
Contact name
Anthony de Soyza
Contact email
Sponsor organisation
Biocompatibles UK Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 3 months, 1 days
Research summary
This longitudinal cohort study is a post market observational, prospective, multicenter cohort study. It is designed to evaluate patient experience with the RePneu™ device for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product. It aligns to a European study and registry allowing UK experiences to be benchmarked. In addition, the study will collect information that will serve as the foundation for a cost effectiveness analysis.
Investigators will be board certified physicians who are interventional
bronchoscopists or thoracic surgeons. Participating sites will have facilities that support the practice of interventional bronchoscopy and offer the RePneu
procedure.
Study participants will be patients who consent to have the RePneu procedure
and with clinical data being collected in the Study.
Participating sites will submit de-identified
Participant data via electronic case
report forms (eCRFs). The information collected by participating sites will be
placed in a web-based
database. Quality of Life (QOL) measures including
Participant experience and satisfaction following this procedure will also be
collected.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0350
Date of REC Opinion
3 Nov 2015
REC opinion
Favourable Opinion