Barrett's Oesophagus - Ablation Procedure with the HALO 90 System
"Removal of the Barrett's epithelium with Focal Radio Frequency Ablation"
DURING THE PROCEDURE
The following is a representation of the procedural steps used for the Ablation of Intestinal Metaplasia Containing Dysplasia Trial (AIM-Dysplasia).
This guide is not meant to replace physician judgment. Procedural steps may vary by patient according to patient tolerability, anatomy, motility, or characteristics of the Barrett's Oesophagus. Refer to the instructions for use for more detailed information.
Using standard endoscopy techniques, the physician activates and controls the various functions of the HALO90 System:
The ablation catheter is mounted onto the endoscope.
With the ablation catheter attached to the distal end of the endoscope, the physician begins the upper endoscopy procedure. Identify and record the areas of the abnormal tissue to be ablated.
By manipulating the endoscope, the ablation catheter is positioned within the oesophagus at the affected portion of the oesophagus.
The physician delivers ablative energy to the targeted tissue. The energy application is less than 1 second and is delivered in an automated manner.
The design of this technology limits the energy delivery to a depth clinically shown to remove the diseased tissue (less than 1 mm) while reducing the risk of injury to the deeper tissue layers.
For patients with more than one area of Barrett's oesophagus, the HALO90 ablation catheter is repositioned and the ablation steps are repeated.