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

NCT ID: NCT01614730

Last Updated: 2012-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-07-31

Brief 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

Keywords

EMS; Modified Device

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Modified Neurotech Vital Device

Checking to see no contraction is stimulated during treatment with the Modified Neurotech Device

Group Type: SHAM_COMPARATOR

Modified Neurotech Vital Device

Intervention Type: DEVICE

verify no contraction is stimulated in the Modified Neurotech Vital.

Neurotech Vital Device

Checking to see a contraction is stimulated during treatment of the Neurotech Vital Device

Group Type: ACTIVE_COMPARATOR

Neurotech Vital Device

Intervention Type: DEVICE

Checking there is a contraction of the pelvic floor muscle when the treatment is administered with the Neurotech Vital Device

Interventions

Modified Neurotech Vital Device

verify no contraction is stimulated in the Modified Neurotech Vital.

Intervention Type: DEVICE

Neurotech Vital Device

Checking there is a contraction of the pelvic floor muscle when the treatment is administered with the Neurotech Vital Device

Intervention Type: DEVICE

Other Intervention Names

Modified Neurotech Vital Device, EMS; EMS, Neurotech Vital

Eligibility Criteria

Inclusion Criteria

• Subjects who are female and at least 18 years of age.
• Subjects who, in the opinion of the Investigator, are deemed healthy.
• Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
• Subjects who are able to understand this study and are willing to complete all the study assessments.

Exclusion Criteria

• Subjects who meet any of the following criteria will be excluded from participation in the study.

• Subjects who have an existing medical condition that would compromise their participation in the study.
• Subjects who have a physical condition that would make them unable to perform the study procedures.
• Subjects with a history of any respiratory condition including a chronic cough.
• Subjects with a history of an underlying neurological condition.
• Subjects with a history of low back pain involving the spinal nerve root.
• Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
• Subjects who have previously had any uro-gynaecological related surgery excluding hysterectomy.
• Subjects with a clinical diagnosis of prolapse greater than Stage 2.
• Subjects who are pregnant or could be pregnant.
• Subjects who are less than 6 months post-partum or who are lactating.
• Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
• Subjects with pelvic pain or fibromyalgia or paravaginal defect.
• Subjects with an active implanted medical device (ie pacemaker, pump etc).
• Subjects with a history of heart disease or stroke.
• Subjects with a known cancer.
• Subjects with an injury or disability affecting any part of their body which will be in contact with the garment.
• Subjects who are currently involved in any injury litigation claims.
• Subjects who have been committed to an institution by virtue of an order issued either by the courts or by an authority.
• Subjects who have participated in a clinical study in the last 3 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bio-Medical Research, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Countries

United States

Other Identifiers

BMR-12-1002

Identifier Type: -

Identifier Source: org_study_id