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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bio-Medical Research, Ltd.
ClinicalTrials.gov Identifier:
NCT01614730
First received: June 6, 2012
Last updated: July 5, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Contraction of Pelvic Floor Muscle Using EMS
Device: Modified Neurotech Vital Device
Device: Neurotech Vital Device
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: User Evaluation Trial in Healthy Volunteers : Modified Neurotech Vital Device

Further study details as provided by Bio-Medical Research, Ltd.:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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?'.


Enrollment: 10
Study Start Date: June 2012
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects who meet the following inclusion criteria will be included in the study.

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Bio-Medical Research, Ltd.
ClinicalTrials.gov Identifier: NCT01614730     History of Changes
Other Study ID Numbers: BMR-12-1002
Study First Received: June 6, 2012
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Bio-Medical Research, Ltd.:
EMS
Modified Device

ClinicalTrials.gov processed this record on July 24, 2014