Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2019-07-02
2019-07-09
Brief Summary
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Detailed Description
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All subjects will sign an informed consent before any study activity. Five (5) potential end users and Additional five (5) contraindicated subjects will be screened for this self-selection study. Subjects will be provided with the device in its original packaging and will be evaluated for their ability to decide if they are eligible or they should self-exclude themselves from use of the device based solely on reading the device labeling (box and user manual).
Once the subjects complete reviewing the labeling materials (box and user manual) they will be requested to perform a labeling comprehension exam for testing the ability to correctly understand the labeling content.
The study will not include treatment.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Toothwave contraindicated subject
the Toothwave toothbrush is contraindicated for people in certain conditions, e.g. pregnant or nursing women, people with pacemaker and more.
This arm is assembled from contraindicated subject, who should exclude themselves from use of the device, based on the user manual and box sleeve.
Toothwave toothbrush
Subjects get the device's box with the user manual and the device. However, they don't use the device, but only read the user manual and fill questionnaires.
potential users of the Toothwave device
The control arm is assembled from people who can use the toothbrush and should recognize themselves as potential users.
Toothwave toothbrush
Subjects get the device's box with the user manual and the device. However, they don't use the device, but only read the user manual and fill questionnaires.
Interventions
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Toothwave toothbrush
Subjects get the device's box with the user manual and the device. However, they don't use the device, but only read the user manual and fill questionnaires.
Eligibility Criteria
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Inclusion Criteria
2. Subject is a potential candidate for purchasing the Silk'n Toothwave Device.
3. Subject is capable of understanding and is willing to sign informed consent.
1. Subject with or an active implant, such as a pacemaker, incontinence device, insulin pump, etc.
2. Subject is pregnant or nursing (lactating).
Exclusion Criteria
2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
3. Pregnant or nursing.
4. Any active condition in the oral cavity at the discretion of the investigator.
5. Any surgery in the oral cavity within 3 months prior to treatment, or before complete healing.
18 Years
90 Years
ALL
Yes
Sponsors
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Home Skinovations Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Judith Hellman, MD
Role: PRINCIPAL_INVESTIGATOR
Hellman Dermatology Clinic
Locations
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Hellman Dermatology clinic
New York, New York, United States
Countries
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Other Identifiers
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DO116508
Identifier Type: -
Identifier Source: org_study_id