Validation Study in Healthy Female Volunteers: A Comparison of Two Neurotech Vital Devices Set up to Provide Different Types of Electrical Stimulation
|Healthy Female Volunteers||Device: Neurotech Vital Device Device: Modified Neurotech Vital Device||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
|Official Title:||Validation Study in Healthy Female Volunteers: A Comparison of Two Neurotech Vital Devices Set up to Provide Different Types of Electrical Stimulation|
- The primary objective of this validation study is to verify that the Modified Neurotech Vital Device does not elicit a pelvic floor contraction compared to the Neurotech Vital Device. [ Time Frame: Day1 ]The primary endpoint of the study is to demonstrate that no volunteers elicit a contraction of the pelvic floor muscle with the Modified Neurotech Vital Device and that all the volunteers elicit a contraction of the pelvic floor muscle with the Neurotech Vital Device. Contraction of the pelvic floor muscles will be assessed by using sonographic/real time ultrasound imaging/recording (mean of three measurements of pelvic floor displacement achieved during maximum threshold intensity electrical stimulation).
- The secondary objective of this validation study is to verify that the Modified Neurotech Vital Device is perceived by the volunteers as a valid treatment option in terms of sensation. [ Time Frame: Day1 ]Subjects will also be asked to complete a feedback questionnaire on the use of the Modified Neurotech Vital Device to verify that it is perceived as a valid treatment option.
|Study Start Date:||June 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Modified Neurotech Vital Device
Checking to observe stimulation delivered using this device
Device: Modified Neurotech Vital Device
5 minute stimulation
Active Comparator: Neurotech Vital Device
Checking to see if stimulation observed using this device
Device: Neurotech Vital Device
5 minute treatment
Other Name: Modified Neurotech Vital Device
The Neurotech Vital Device is connected to a series of conductive hydrogel electrodes strategically positioned in and around the pelvic area of the user. The electrode positions and current pathways deliver therapeutic stimulation to the pelvic floor muscles resulting in repeated contraction of the intended muscle group. Pilot study data has shown this novel approach to produce extremely favorable adaptation and improvement in patient's symptoms following intervention. In order to capture the intended electrode position a stand-alone garment that will allow the end user to re-position electrodes on multiple re-applications is required. The Neurotech Vital Device garment is CE Marked as a Class IIa medical device and it is CE Marked, as part of the Neurotech Vital Device, in line with Medical Device Directive 93/42/EC as amended by 2007/47/EC. The Neurotech Vital Device garment is not cleared by the FDA through the 510 (k) pre-market notification process in the USA but would be considered a Class II device as part of the Neurotech Vital Device.
The purpose of this validation study is to establish the suitability of the Neurotech Vital device in which the treatment stimulation parameters have been markedly attenuated (defined as 'modified Neurotech Vital device') prior to its use as one of the treatments in a randomised, controlled, double-blind study to be conducted in patients with stress urinary incontinence in Germany (Study No: BMR-11-1002).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632748
|United States, Georgia|
|North Georgia College and State University|
|Dahlonega, Georgia, United States, 30597|