WAVE Global
Research type
Research Study
Full title
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Multi-Center, Prospective, Post-Market, Confirmatory, Interventional, Investigation
IRAS ID
291480
Contact name
Nicholas Inston
Contact email
Sponsor organisation
BD
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
The WAVE Global study, is a multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creations by means of the WavelinQ™ EndoAVF System in patients who require vascular access for hemodialysis (HD).
The medical device that is being examined in this clinical study is the WavelinQ™ EndoAVF System. The manufacturer of the WavelinQ™ EndoAVF System is Bard Peripheral Vascular, Inc. (Bard)
The WavelinQ™ EndoAVF System carries a CE-mark, meaning that it complies with the regulations of being marketed in the European Union (EU). The WavelinQ™ EndoAVF System has been available on the European market since 2014. In this investigation, the WavelinQ™ EndoAVF System will be used exclusively according to its intended use.
The purpose of this clinical investigation is to provide clinical evidence to further demonstrate reasonable assurance of safety and effectiveness of the WavelinQ™ EndoAVF System for endovascular fistula (endoAVF) creations in a post-market confirmatory interventional fashion.
A target of approximately 15 investigational sites (up to a maximum of 30 investigational sites) will be included in this investigation and distributed globally outside the US.
Treated participants will be followed for 24-months post index procedure. The enrollment period is estimated to last about 18 months and the total clinical investigation duration is estimated to last 3.5 years from the enrollment of the first participant to the last follow-up visit of the last active treated participant. The primary endpoints will be analyzed when the last active treated participant has completed their 6-month follow-up. A final analysis will be completed when all participants have completed, or prematurely discontinued before, their 24-month follow-up.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0231
Date of REC Opinion
17 Nov 2021
REC opinion
Further Information Favourable Opinion