PMID- 36250521
OWN - NLM
STAT- MEDLINE
DCOM- 20230306
LR  - 20230606
IS  - 1478-596X (Electronic)
IS  - 1478-5951 (Linking)
VI  - 19
IP  - 2
DP  - 2023 Apr
TI  - Clinical safety and efficacy of a fully automated robot for magnetic resonance 
      imaging-guided breast biopsy.
PG  - e2472
LID - 10.1002/rcs.2472 [doi]
AB  - BACKGROUND: Magnetic resonance imaging (MRI)-guided biopsies are an accurate, but 
      technically challenging, method for screening and diagnosis of breast lesions. 
      This study assesses the safety and efficacy of an Image Guided Automated Robot 
      (IGAR) in performing breast biopsies compared to manual procedures. METHODS: 
      Safety was determined from adverse events (AEs) and device deficiencies. Efficacy 
      was assessed using targeting accuracy, number of successful biopsies, pain and 
      scar scores, patient discomfort, and radiologist-determined ease-of-use. RESULTS: 
      All seven procedures in phase I were successfully and safely completed with no 
      AEs and one device deficiency. The 23 IGAR biopsies in phase II outperformed the 
      18 manual biopsies in 1-week pain scores (p = 0.027), scarring at 1-week 
      (p = 0.035), 1-month (p = 0.004), and components of comfort and ease-of-use. 
      Phase II had seven and three AEs in the IGAR and manual groups, respectively 
      (p = 0.317), with no serious AEs and nine device deficiencies. CONCLUSIONS: The 
      IGAR system is safe and effective for breast biopsy procedures. The results from 
      these trials indicate the IGAR system as a potentially viable alternative to 
      manual breast biopsy procedures.
CI  - (c) 2022 John Wiley & Sons Ltd.
FAU - Anvari, Mehran
AU  - Anvari M
AUID- ORCID: 0000-0001-7256-5789
AD  - Centre for Surgical Invention and Innovation (CSii), McMaster University, 
      Hamilton, Ontario, Canada.
FAU - Chapman, Trevor
AU  - Chapman T
AD  - Centre for Surgical Invention and Innovation (CSii), McMaster University, 
      Hamilton, Ontario, Canada.
FAU - Barlow, Karen
AU  - Barlow K
AUID- ORCID: 0000-0001-6681-6668
AD  - Centre for Surgical Invention and Innovation (CSii), McMaster University, 
      Hamilton, Ontario, Canada.
FAU - Cookson, Tyler
AU  - Cookson T
AD  - Centre for Surgical Invention and Innovation (CSii), McMaster University, 
      Hamilton, Ontario, Canada.
FAU - Van Toen, Carolyn
AU  - Van Toen C
AD  - MCDonald Detwiller & Associates (MDA), Brampton, Ontario, Canada.
FAU - Fielding, Tim
AU  - Fielding T
AD  - MCDonald Detwiller & Associates (MDA), Brampton, Ontario, Canada.
LA  - eng
GR  - Network Centres of Excellence/
GR  - Centres of Excellence for Commercialization and Research program/
PT  - Journal Article
DEP - 20221025
PL  - England
TA  - Int J Med Robot
JT  - The international journal of medical robotics + computer assisted surgery : MRCAS
JID - 101250764
SB  - IM
EIN - Int J Med Robot. 2023 Aug;19(4):e2540. PMID: 37278247
MH  - Humans
MH  - Female
MH  - *Robotics
MH  - Breast/diagnostic imaging
MH  - Image-Guided Biopsy/adverse effects/methods
MH  - Biopsy/adverse effects/methods
MH  - Magnetic Resonance Imaging/methods
MH  - Pain/pathology
MH  - *Breast Neoplasms/diagnostic imaging
OTO - NOTNLM
OT  - MRI-compatible
OT  - automated robot
OT  - biopsy
OT  - breast cancer
OT  - lesion
EDAT- 2022/10/18 06:00
MHDA- 2023/03/07 06:00
CRDT- 2022/10/17 06:34
PHST- 2022/10/05 00:00 [revised]
PHST- 2022/07/15 00:00 [received]
PHST- 2022/10/16 00:00 [accepted]
PHST- 2022/10/18 06:00 [pubmed]
PHST- 2023/03/07 06:00 [medline]
PHST- 2022/10/17 06:34 [entrez]
AID - 10.1002/rcs.2472 [doi]
PST - ppublish
SO  - Int J Med Robot. 2023 Apr;19(2):e2472. doi: 10.1002/rcs.2472. Epub 2022 Oct 25.