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 (BMR-12-1002)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01614730|
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : July 9, 2012
Bio-Medical Research, Ltd.
Information provided by (Responsible Party):
Bio-Medical Research, Ltd.
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.
|Condition or disease||Intervention/treatment||Phase|
|Contraction of Pelvic Floor Muscle Using EMS||Device: Modified Neurotech Vital Device Device: Neurotech Vital Device||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||User Evaluation Trial in Healthy Volunteers : Modified Neurotech Vital Device|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||July 2012|
Sham Comparator: Modified Neurotech Vital Device
Checking to see no contraction is stimulated during treatment with the Modified Neurotech Device
Device: Modified Neurotech Vital Device
verify no contraction is stimulated in the Modified Neurotech Vital.
Other Name: Modified Neurotech Vital Device, EMS
Active Comparator: Neurotech Vital Device
Checking to see a contraction is stimulated during treatment of the Neurotech Vital Device
Device: Neurotech Vital Device
Checking there is a contraction of the pelvic floor muscle when the treatment is administered with the Neurotech Vital Device
Other Name: EMS, Neurotech Vital
Primary Outcome Measures :
- Using a sonographic/real time ultrasound imaging machine detect if a contraction is stimulated by the 5 minute treatment with the modified Neurotech Device and 5 minute treatment with the Neurotech Vital Device. [ Time Frame: 5 minutes treatment with each device to measure if contraction occurrs on the ultrasound ]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).
Secondary Outcome Measures :
- Healthy Volunteers feedback questionnaires [ Time Frame: after 5 minutes of treatment ]The secondary objective of this user evaluation study is to verify that the Modified Neurotech Vital Device is perceived by the volunteers as a valid treatment option. The Modified Neurotech Vital Device will be considered an acceptable treatment option in relation to stimulation sensation if 70% yes/not sure responses are obtained to the question 'given what you have been told about this treatment, do you believe it could be effective?'.
No Contacts or Locations Provided