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 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
NCT ID:
NCT03316105
Group ID:
EG000
Title:
TENS Unit Stimulation
Description:
During this TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will take pressure readings after being placed. After four hours, subjects will again be given a second meal. Fifteen minutes of electrical stimulation will be given to subjects fifteen minutes before ingestion of lunch. After ingestion of lunch, 60 minutes of the electrical stimulation will be applied. When the test is done, the tube will be removed.
Elira Investigational TENS device: TENS unit placed on skin will deliver electric stimulation to abdominal area.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
9
Other Number Affected:
0
Other Number At Risk:
9
Study:
NCT03316105
Results Section:
NCT03316105
Adverse Events Module:
NCT03316105