ARTIA
Research type
Research Study
Full title
A Prospective, Non-Interventional, Post Market Clinical Follow-up Study to Evaluate the Safety of Pre-Pectoral Breast Reconstruction with ARTIA™ Reconstructive Tissue Matrix after Mastectomy
IRAS ID
306600
Contact name
John Murphy
Contact email
Sponsor organisation
AbbVie
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a prospective, non-interventional, multi-center, single arm cohort study in Europe designed to follow adult female patients undergoing either direct-to-implant or two-stage breast reconstruction surgery with pre-pectoral technique using ARTIA™ for 12 months after ARTIA™ placement. The frequency and purpose of all interactions between patients and surgeons are determined by standard of care practices and are at the discretion of the surgeon and patient. All data captured for study purposes will include patient demographic and clinical information that is being collected for routine standard of care purposes.\nThe study will analyze approximately 144 breast reconstructions with ARTIA™ in sites in the United Kingdom and Italy. It is estimated that 150 patients are to be consented and enrolled, and 20% of them will not be eligible intra-operatively. Thus, 120 patients will undergo the breast reconstructions with ARTIA™ and be included in the safety population. \nThe estimated duration of the study is 3 years. The study will plan to recruit patients for up to 2 years, however the duration is dependent upon site feasibility and ability to enroll. Follow-up period will be approximately 12 months following placement of ARTIA™.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0231
Date of REC Opinion
31 Aug 2022
REC opinion
Further Information Favourable Opinion