A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults
This study has been completed.
University of California, San Diego
Information provided by:
First received: July 22, 2008
Last updated: September 17, 2008
Last verified: September 2008
A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Probe Study of the Tolerability of an Investigational Electroporation Device, MedPulser (Trademark) DNA Delivery System (DDS) in Healthy Adults 18 to 35 Years of Age|
Further study details as provided by Merck:
Primary Outcome Measures:
- Assess the tolerability of the MedPulser DDS device. [ Time Frame: Severity of pain will be measured at time of treatment and 1, 5, 10, and 20 minutes and 24 hours after electrostimulation. ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Study Completion Date:||October 2005|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
Intramuscular injection of phosphate buffered saline solution will be given and within 2 - 5 minutes will be followed by an electrostimulation pulse with the MedPulser DDS in the deltoid muscle of the right arm. 15 days later, the same procedure will take place using the left arm.
Contacts and Locations