Probe-based Confocal Laser Endomicroscopy (pCLE)

What does "pCLE" refer to exactly ?
Probe-based Confocal Laser Endomicroscopy (pCLE) is a newly developed technique that provides real-time microscopic visualization of mucosal tissue during normal endoscopic procedures. Cellvizio is the only available pCLE system today. The images that you will obtain with Cellvizio^®-GI have a resolution 500 to 1000 times greater than a regular endoscope. Cellvizio^®-GI greatly enhances the capabilities of your endoscopes.

How do you mean ? Is Cellvizio^®-GI a new type of endoscope for GI applications ?
No, Cellvizio^®-GI is not a stand-alone endoscope but an accessory that you may use with your existing endoscopes, provided the operating channel has a diameter of 2.8 mm or more.

So, Cellvizio^®-GI is like a miniprobe that I can pass through the accessory channel of my scope ?
Exactly. Just like any other accessory, you can pass the flexible element of Cellvizio^®-GI through your scope. Cellvizio^®-GI is really a three-element system:
- An advanced "light processor" called the Laser Scanning Unit which takes care of emitting a very high quality laser beam and detecting the light that's coming back from the tissue.
- A miniprobe, that is made of 30,000 individual optical fibers carefully arranged and terminated by microlenses at the distal end. The confocal miniprobe plugs in the Laser Scanning Unit thanks to a very specific and precise connector. The outer diameter of the miniprobes is 2.5 mm (or about 8 French) so it passes through accessory channels of 2.8 mm or more. We call the confocal miniprobes ColoFlex and GastoFlex.
- A software which enables real-time visualization of dynamic digital sequences and of course saving of the sequences in convenient formats for later examination, editing or archiving.

Wow, so I can use this super thin probe to make microscopic images in real-time on the mucosa ? how does this work ?
Over the past 5 years, Mauna Kea Technologies has developed a unique technology for endoscopic microscopy called Fibered Confocal Fluorescence Endoscopy. Mauna Kea Technologies' technological solution is based on optics, fast electronics and real time image processing. In short, a very high quality and low power laser beam is scanned into the tens of thousands of optical fibers of the catheter and is thus transported to the tissue. The light coming back from the tissue follows the same path in reverse and falls onto an ultra-sensitive detector. Electronics reconstruct the image from the detector's signal and pass it to the image processing engine which then displays the image.

There are so many optical fibers to be addressed, can the imaging take place in real time ?
Indeed ! Mauna Kea Technologies' laser scanning technology is so fast that the laser beam addresses each of the 30,000 fibers (or more) 12 times per second. But that's not all: our algorithms are so fast that the image processing takes place on the fly ! So this is true real time imaging, where real time means quasi video rate. What you are seeing is a video sequence of 12 images per second, which appears exactly like a regular video on your screen. Such a fast frame rate greatly helps reducing motion artifacts and it is easy to obtain stable images.

You mentioned that your confocal miniprobes have to be in contact with the tissue. Is this a requirement ?
Absolutely. There will be no images on your screen if the confocal miniprobe is not in contact with the tissue. There is no need for extra pressure, you just need to place the tip of the probe on the surface of the mucosa. This gesture is similar to the one you perform everyday with your biopsy forceps. The great thing is that while you are using the confocal miniprobe, you keep the benefits of your endoscopic field-of-view. It is then easy to position the miniprobe.

How flexible are the ColoFlex and GastroFlex probes ? can I still use my scope as usual while using Cellvizio^®-GI ?
Precisely. This is what we've applied our minds to: keeping your practice as usual as possible. Our ColoFlex and GastroFlex probes won't be a hindrance to the normal use of your scopes. You can reach almost any configuration of your scope while our probes are inserted into it. However, you might want to refrain from unusually tight bending of your scope to avoid potential damages to the probe. Please refer to our detailed Spec Sheet for that.

How does this compare with high-magnification endoscopy in terms of resolution ?
When doing fluorescence imaging, resolution depends both on what is fluorescing and on the intrinsic resolution of the instrument. Cellvizio^®-GI has an equivalent magnification 10 to 50 times greater than high magnification endoscopes.

Are the ColoFlex and GastroFlex probes disposable or reprocessable ? If so, how do I reprocess them ?
The ColoFlex and GastroFlex probes are reprocessable. The procedure for reprocessing is the standard disinfection procedure for your endoscope.

Has Cellvizio^®-GI been used in clinical trials ?
Yes. Cellvizio^®-GI has been used by several clinical teams. Please refer to our GI Endoscopy pages for more information on the subject.

Has Cellvizio^®-GI been cleared by FDA and/or obtained the CE Mark ?
Yes. Cellvizio^®-GI has received both FDA clearance and the CE Mark for use in the GI tract, for its 488 nm and 660 nm versions. The indications for use stated in the FDA 510k approval are : Mauna Kea Technologies Cellvizio^®-GI is a confocal laser imaging system with fiber optic probes that is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract, i.e., gastrointestinal or pulmonary, accessed by the endoscope.