Results from the trial were presented at the United European gastroenterology Week 2017 meeting, the Paris-based company said.
The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level. The system allows the operating physician to visualize the internal microstructure of tissue in real time during ureteroscopic and cytoscopic procedures, Mauna Kea said.
Data in the Contact study came from 217 patients at 5 clinics in France, the company said, and showed that the use of Cellvizio altered 30% of diagnoses and improved diagnostic inter-observer agreement from 0.45 to 0.76.
Use of the device also reportedly changed 28% of patient management strategies, prevented 42% of patients with benign cysts from undergoing continued surveillance and reversed choices between surveillance and surgery in 15% of pre-malignant lesions.
“Previous results from the contact study already validated the very high sensitivity and specificity of endomicroscopy for the diagnosis pancreatic cystic lesions, which remained until now a major diagnostic issue for clinicians. With these new data from the Contact study, we have shown that the use of Cellvizio allows clinicians to alter, with a high confidence level, their treatment decisions. Overall, these results from the Contact study continue to support the recognition of endomicroscopy as an integral part of the standard of care in patients with pancreatic cystic lesions,” Dr. Bertrand Napoleon, who presented the study results, said in a press release.
Mauna Kea touted a number of other presentations at the conference featuring its Cellvizio technology, including the use of it to detect colonic mucosa micro-inflammation and Chron’s disease.
“This year at UEGW we are highlighting the ability of needle-based confocal laser endomicroscopy with Cellvizio to address diagnostic uncertainties in pancreatic cysts, which is a well-known and hard-to-achieve medical challenge. This study demonstrates the potential benefit of using Cellvizio as a standard of care for this major application,” CEO Sacha Loiseau said in a prepared statement.