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出境医 / 临床实验 / Self-selection Study of the Toothwave Toothbrush

Self-selection Study of the Toothwave Toothbrush

Study Description
Brief Summary:
This study objective is to test the Silk'n Toothwave self-selection, by potential end users. Additionally, this study will evaluate if contraindicated subjects will self-exclude from use of the device and the ability to understand accurately the labeling content (box and user manual).

Condition or disease Intervention/treatment Phase
Gingivitis Plaque Calculus Tooth Discoloration Device: Toothwave toothbrush Not Applicable

Detailed Description:

The Silk'n Toothwave Device, in its original packaging, along with the user manual will be provided to the patient in a simulated home use environment. The patient labeling will be in the format intended for distribution.

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 5 participants are suppose to exclude themselves from the use of the device, while the 5 others should claim they can use it.
Masking: Single (Participant)
Masking Description: Before they start their part in the study, participants won't be aware if they can use the brush or not.
Primary Purpose: Screening
Official Title: Self-selection Study to Confirm the "Toothwave" Labeling and User Manual Are Clear Enough for Contraindicated Users to Self-exclude Themselves From Using the Device
Actual Study Start Date : July 2, 2019
Actual Primary Completion Date : July 9, 2019
Actual Study Completion Date : July 9, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.

 Device: 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.
Active Comparator: 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.
 Device: 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.
Outcome Measures
Primary Outcome Measures :
  1. Subjects will mention in the post-reading questionnaire if they should use the Toothwave device or not. [ Time Frame: 30 minutes ]
    Post-reading questionnaire includes the question: "are you allowed to use this device?". Based on reading the user manual and box labeling, subjects should answer "yes" or "no" according to their condition.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject is male or female equal to or greater than 18 years of age.
  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.

Exclusion Criteria:

  1. Current or history of oral cavity cancer or oropharyngeal cancer.
  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.

Modified Inclusion Criteria for contraindicated subjects:

  1. Subject with or an active implant, such as a pacemaker, incontinence device, insulin pump, etc.
  2. Subject is pregnant or nursing (lactating).
Contacts and Locations

Locations
Layout table for location information
United States, New York
Hellman Dermatology clinic
New York, New York, United States, 10019
Sponsors and Collaborators
Home Skinovations Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Judith Hellman, MD Hellman Dermatology Clinic
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date November 24, 2020
Actual Study Start Date  ICMJE July 2, 2019
Actual Primary Completion Date July 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019) 		Subjects will mention in the post-reading questionnaire if they should use the Toothwave device or not. [ Time Frame: 30 minutes ]
Post-reading questionnaire includes the question: "are you allowed to use this device?". Based on reading the user manual and box labeling, subjects should answer "yes" or "no" according to their condition.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-selection Study of the Toothwave Toothbrush
Official Title  ICMJE Self-selection Study to Confirm the "Toothwave" Labeling and User Manual Are Clear Enough for Contraindicated Users to Self-exclude Themselves From Using the Device
Brief Summary This study objective is to test the Silk'n Toothwave self-selection, by potential end users. Additionally, this study will evaluate if contraindicated subjects will self-exclude from use of the device and the ability to understand accurately the labeling content (box and user manual).
Detailed Description

The Silk'n Toothwave Device, in its original packaging, along with the user manual will be provided to the patient in a simulated home use environment. The patient labeling will be in the format intended for distribution.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
5 participants are suppose to exclude themselves from the use of the device, while the 5 others should claim they can use it.
Masking: Single (Participant)
Masking Description:
Before they start their part in the study, participants won't be aware if they can use the brush or not.
Primary Purpose: Screening
Condition  ICMJE
  • Gingivitis
  • Plaque
  • Calculus
  • Tooth Discoloration
Intervention  ICMJE Device: 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.
Study Arms  ICMJE
  • Experimental: 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.

    Intervention: Device: Toothwave toothbrush
  • Active Comparator: 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.
    Intervention: Device: Toothwave toothbrush
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2019) 		10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 9, 2019
Actual Primary Completion Date July 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is male or female equal to or greater than 18 years of age.
  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.

Exclusion Criteria:

  1. Current or history of oral cavity cancer or oropharyngeal cancer.
  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.

Modified Inclusion Criteria for contraindicated subjects:

  1. Subject with or an active implant, such as a pacemaker, incontinence device, insulin pump, etc.
  2. Subject is pregnant or nursing (lactating).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04023097
Other Study ID Numbers  ICMJE DO116508
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Home Skinovations Ltd.
Study Sponsor  ICMJE Home Skinovations Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Judith Hellman, MD Hellman Dermatology Clinic
PRS Account Home Skinovations Ltd.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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