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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
NCT ID:
NCT05278858
Group ID:
EG000
Title:
MedJet Device
Description:
The Med-Jet-MBX needle-free injector (Med-Jet) is a novel, needle-free drug-delivery system, which we believe may be a solution to the pain and fear associated with needles. It uses regulated compressed air as a power source to accelerate an injectable fluid through a 0.005" orifice (6x smaller than a 30G needle) to penetrate the skin and deliver medication to a specific anatomical region (MedJet) The drug-delivery device is highly configurable allowing adjustable depth and volume parameters (MedJet). In addition, the high-performance design allows for triggering multiple injection sites rapidly which is practical when needing to treat large surface areas (MedJet).
MedJet Device with intralesional triamcinolone: A standard sterile disposable 5 ml syringe will be used to draw TAC using standard sterile protocol. This syringe will be attached to the Med-Jet along with a sterile barrel and disposable sterile tip. The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.1 ml of injected fluid). The optimal injection pressure used on the subject will start at 110 pounds per square inch (psi) and increased by 10 psi until a blanching wheal is observed. The optimal pressure will be recorded. The injections will be repeated multiple times at the optimal pressure until the targeted patch is completely treated.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
3
Other Number Affected:
1
Other Number At Risk:
3
Study:
NCT05278858
Results Section:
NCT05278858
Adverse Events Module:
NCT05278858