Patient
Resources

Sources

1. Waxman I. et al. First Assessment of Needle-based Confocal Laser Endomicroscopy (nCLE) During EUS-FNA Procedures of the Pancreas. Gastrointestinal Endoscopy, 2011.

2. Konda V.J. et al. An International, Multi-Center Trial on Needle-Based Confocal Laser Endomicroscopy (nCLE): Results From the In Vivo CLE Study in the Pancreas With Endosonography of Cystic Tumors (INSPECT). Poster at the Digestive Disease Week congress, 2012.

3. Nakai Y. et al. Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound, Through-the-Needle Confocal Laser- Induced Endomicroscopy and Cystoscopy Trial (DETECT Study). Oral presentation at the American College of Gastroenterology congress, 2012.

4.Giovannini M. et al. Feasibility of Intratumoral Confocal Microscopy under Endoscopic Ultrasound Guidance. Endoscopic Ultrasound, 2012.

5. Samarasena J_8 etal, Endoscopic Ultrasonography GUided fine Needle Aspiration of Pancreatic Cystic Lesions I A practical Approach to diagnosis ans Management Gastrointestinal Endoscopy Clinics of North America 2012.

6. Napoléon B. et al. Interest of needle-based confocal laser endomicroscopy for the diagnosis of serous cystadenomas (CONTACT study). Poster, presented at DDW 2013.

a. Traditional pathological examination of tissue samples remains the “gold standard” for evaluating tissue abnormalities and the presence of cancer. Optical Biopsy has been demonstrated to facilitate this traditional sampling and under certain conditions even potentially reduce the need for traditional examination.

b. The effectiveness of the Cellvizio system for assisting physicians in detecting cancer has not been evaluated by the U.S. FDA. These statements are not intended as claims of effectiveness or safety for these specific indications.

c. The Cellvizio Systems ability to help facilitate cancer detection is dependent upon the skill and experience of the physician using the system.