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:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
NCT ID:
NCT03811093
Group ID:
EG001
Title:
Sham Group
Description:
A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Sham Group: Each participant randomly assigned to the "Sham Group" will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
15
Other Number Affected:
0
Other Number At Risk:
15
Study:
NCT03811093
Results Section:
NCT03811093
Adverse Events Module:
NCT03811093