Gastric Disease
Cellvizio® is the real-time in vivo cellular imaging platform that is an adjunct to the standard of care and allows you to monitor the progression of Gastric Intestinal Metaplasia over time.
In 2018, 1 million new cases of gastric cancer were diagnosed1 with a 5 year survival rate of 31%.2
Given these statistics, it is now the 3rd most common cause of cancer related deaths.1 In cases where gastric cancer progresses more slowly over time, Cellvizio enables you to detect and monitor cellular changes in vivo using proprietary advanced imaging technology.
Cellvizio® Clinical Value
Cellvizio® provides physicians with microscopic images of tissue during standard endoscopies, in real-time, which enables a reliable diagnosis of Gastric Intestinal Metaplasia (GIM).3
pCLE combined with targeted conventional endoscopic biopsies allows the detection of Gastric Cancer with an accuracy of 98%.4 Cellvizio’s targeted biopsies also decrease randomized biopsies by 68%.3,4
“CLE is trustworthy to make on-the-spot decisions on the diagnosis of early gastric cancer, the strategy of endoscopic treatment and follow-up"
-- Prof. Yanqing Li, Qilu Hospital Shandong University
Patient Management
In addition to localizing lesions and targeting biopsies4, physicians with Cellvizio® can detect gastric cancer with an accuracy of 92%,4 as well as evaluate margins before, during and after endoscopic resection.5,6
Cellvizio® mucosal assessment
using Cellvizio® GastroFlexTM UHD Miniprobe
Healthy tissue
Criteria: funded glands, regular ranged glands, homogeneous in size and epithelial heights
Gastric Intestinal Metaplasia
Criteria: columnar epithelium with villous appearance, large black goblet cells, vessels with normal calibre
Stomach Cancer
Criteria: atypical/naive glands with dark epithelium, increased calibre and vessels irregular in size and shape
1. World Health Organization: International Agency for Research on cancer, 2018, http://gco.iarc.fr/today/online-analysis-table?v=2018&mode=cancer&mode_population=continents&population=900&populations=900&key=asr&sex=0&cancer=39&type=
1&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&nb_items=5&group_
cancer=1&include_nmsc=1&include_nmsc_other=1
2. Harada et al. Recent trend in gastric cancer treatment in the USA, Journal of Cancer Metastasis and Treatment, 2018.
3. Li Zhen et al. Confocal laser endomicroscopy for in vivo detection of gastric intestinal metaplasia: a randomized controlled trial, Endoscopy, 2013
4. Bok G.H. et al. The Accuracy of probe-based Confocal Endomicroscopy versus Conventional Endoscopic Biopsies for the Diagnosis of Superficial Neoplasia (with videos). Gastro-Intestinal Endoscopy, 2013.
5. Ji R, Zuo XL, Li CQ, Zhou CJ, Li YQ. Confocal endomicroscopy for in vivo prediction of completeness after endoscopic mucosal resection. Surg Endosc 2011; 25: 1933-1938
6. Jeon SR, Cho WY, Jin SY, Cheon YK, Choi SR, Cho JY. Optical biopsies by confocal endomicroscopy prevent additive endoscopic biopsies before endoscopic submucosal dissection in gastric epithelial neoplasias: a prospective, comparative study. Gastrointest Endosc 2011; 74: 772-780
Cellvizio® I.V.E. with Confocal Miniprobes™ are regulated Medical Devices, CE marked (CE 0459) (Class IIa - NB : G-MED) and FDA cleared. Cellvizio® is a registered trademark and Confocal Miniprobe™ is a trademark of Mauna Kea Technologies. Cellvizio® I.V.E. with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture. Once connected to the Cellvizio® I.V.E.: The GastroFlex™ UHD and ColoFlex™ UHD Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. Please consult labels and instructions for use. These statements and the associated reference to specific clinical studies, are not intended to represent claims of safety or effectiveness for detecting or treating any specific condition or disease state. Rather this information is intended to provide useful reference to selected published literature describing physician experiences with the associated clinical uses. Any diagnostic assessment should always be made by the attending physician, based on the evaluation of all sources of clinical, endoscopic and other relevant information. These statements have not been reviewed, cleared, or approved by the U.S. FDA. The use of this medical device is exclusively reserved for health professionals. Product availability cannot be guaranteed in all countries. For further information, please contact your local sales representative.
