Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-25 @ 3:18 PM
NCT ID:
NCT00489268
Group ID:
EG004
Title:
Phase II
Description:
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett's tissue or buried Barrett's glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett's (2 cm or less) or for follow-up treatment for small Barrett's islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm\^2. All Halo 360 treatments performed at 10 J/cm\^2; All Halo 90 treatments performed at 12 J/cm\^2
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
70
Other Number Affected:
0
Other Number At Risk:
70
Study:
NCT00489268
Results Section:
NCT00489268
Adverse Events Module:
NCT00489268