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 Clinical Trial

Official title: Validation Study in Healthy Female Volunteers: A Comparison of Two Neurotech Vital Devices Set up to Provide Different Types of Electrical Stimulation

Status Completed

Clinical Trial Summary

This research is being carried out in order to compare two alternative versions of the Neurotech Vital Devices which have been set up to provide two different types of stimulation. Both these devices will be fully functioning devices and the investigators want to collect information on your perception of the two alternative modes. The patient will be asked to provide feedback on both devices which will look identical. The patient will not be told in which order the units were given to them until the completion of your visit.

Clinical Trial Description

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). ;

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy Female Volunteers

• NCT number: NCT01632748
• Study type: Interventional
• Source: Bio-Medical Research, Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: June 2012
• Completion date: August 2012