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 @ 4:16 PM
Ignite Modification Date:
2025-12-25 @ 2:14 PM
NCT ID:
NCT03555266
Group ID:
EG001
Title:
Sham NSS-2 BRIDGE and ERAS Protocol
Description:
The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol
Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
27
Other Number Affected:
1
Other Number At Risk:
27
Study:
NCT03555266
Results Section:
NCT03555266
Adverse Events Module:
NCT03555266