NCT01614730

User Evaluation in Healthy Volunteers to Verify no Pelvic Floor Contraction is Stimulated When the Modified Neurotech Vital Device is Used Compared to the Neurotech Vital Device

User Evaluation Trial in Healthy Volunteers : Modified Neurotech Vital Device

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Bio-Medical Research, Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This user evaluation study is to verify that the Modified Neurotech Vital Device does not stimulate the pelvic floor muscles compared with the Neurotech Vital Device.

Detailed description

This user evaluation study is to verify that the Modified Neurotech Vital Device does not stimulate the pelvic floor muscles compared with the Neurotech Vital Device. Stimulation of the pelvic floor muscles will be assessed by using sonographic/real time ultrasound imaging/recording with displacement measurement using onscreen callipers on the sonogram unit to assess contractions.

Conditions

• Contraction of Pelvic Floor Muscle Using EMS

Interventions

Type	Name	Description
DEVICE	Modified Neurotech Vital Device	verify no contraction is stimulated in the Modified Neurotech Vital.
DEVICE	Neurotech Vital Device	Checking there is a contraction of the pelvic floor muscle when the treatment is administered with the Neurotech Vital Device

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2012-06-08
• Last updated: 2012-07-09