Contraction of Pelvic Floor Muscle Using EMSEarly Phase 1BMR-12-1002NCT01614730
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
A Early Phase 1 study testing Modified Neurotech Vital Device and Neurotech Vital Device in people with Contraction of Pelvic Floor Muscle Using EMS, run by Bio-Medical Research, Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraction of Pelvic Floor Muscle Using EMS
- What is being tested?
- Modified Neurotech Vital Device and Neurotech Vital Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jul 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: User Evaluation Trial in Healthy Volunteers : Modified Neurotech Vital Device
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.
Read the 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.
- Being tested
- Modified Neurotech Vital Device, Neurotech Vital Device
- Keywords
- EMS, Modified Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Neurotech Vital DeviceDevice
Also called Modified Neurotech Vital Device, EMS
verify no contraction is stimulated in the Modified Neurotech Vital.
Neurotech Vital DeviceDevice
Also called EMS, Neurotech Vital
Checking there is a contraction of the pelvic floor muscle when the treatment is administered with the Neurotech Vital Device
| Study group | Role | What they receive |
|---|---|---|
| Modified Neurotech Vital Device | Sham comparator | Checking to see no contraction is stimulated during treatment with the Modified Neurotech Device Receives: Device: Modified Neurotech Vital Device |
| Neurotech Vital Device | Active comparator | Checking to see a contraction is stimulated during treatment of the Neurotech Vital Device Receives: Device: Neurotech Vital Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: 5 minutes treatment with each device to measure if contraction occurrs on the ultrasound
Secondary outcomes (1)
Healthy Volunteers feedback questionnaires
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?'.
Measured: after 5 minutes of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraction of Pelvic Floor Muscle Using EMSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Medical Research, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614730
- Sponsor's protocol ID
- BMR-12-1002
- Acronym
- BMR-12-1002
- Status last verified
- Jun 2012
- First submitted
- 6 Jun 2012
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Evaluation Trial in Healthy Volunteers : Modified Neurotech Vital Device
- ClinicalTrials.gov ID
- NCT01614730
- Acronym / sponsor ID
- BMR-12-1002 / BMR-12-1002
- Keywords
- EMS, Modified Device
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bio-Medical Research, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Neurotech Vital Device | Sham comparator | Device: Modified Neurotech Vital DeviceChecking to see no contraction is stimulated during treatment with the Modified Neurotech Device |
| Neurotech Vital Device | Active comparator | Device: Neurotech Vital DeviceChecking to see a contraction is stimulated during treatment of the Neurotech Vital Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- Subjects who meet any of the following criteria will be excluded from participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Neurotech Vital DeviceAlso: Modified Neurotech Vital Device, EMSverify no contraction is stimulated in the Modified Neurotech Vital. | Device | Modified Neurotech Vital Device |
| Neurotech Vital DeviceAlso: EMS, Neurotech VitalChecking there is a contraction of the pelvic floor muscle when the treatment is administered with the Neurotech Vital Device | Device | Neurotech Vital Device |
Primary outcome
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).
1 secondary outcome
Healthy Volunteers feedback questionnaires
Time frame: after 5 minutes of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Modified Neurotech Vital Device and Neurotech Vital Device in people with Contraction of Pelvic Floor Muscle Using EMS, run by Bio-Medical Research, Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2012.