SaliPen Human Factors Study for OTC Labeling

Study Overview
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Brief Summary
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This Human Factors Validation Testing will assess user interactions to verify the capability of potential users to assess if the study product fits their needs and if they can use it correctly based on the provided Information For User (IFU)? More specifically, this is a non-comparative case series study and is subdivided into two major parts. Those parts are: Phase I: aimed at testing if, based on the IFU, the potential subjects can decide whether the study product is or is not appropriate to treat their condition and, Phase II: aimed at assessing whether the users can use the study product correctly without counseling by a health care provider.

Detailed Description
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Phase I To simulate an OTC setting, potential subjects will be requested to read the label text on the outside of the study product package (external labeling) and determine whether the study product addresses their needs, without a provider direction or assistance. Phase II The study product will be dispensed only to those subjects who will indicate that they voluntarize to participate in this phase of the study. At Phase II subjects with xerostomia and that are willing to try the study product, will be requested to use it with no training, except for their understanding of the User Manual (internal labeling). Those subjects will use the study product in a supervised clinical setting. Subjects who report any discomfort will be offered the option to pause and remove the device upon such a request. Correct use verification will be performed by the study investigators. Subjects will answer questions regarding product use, clarity of the IFU, ease of use, etc. Subjects will also receive an exam of their oral cavity.

Official Title
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SaliPen Human Factors Study for OTC Labeling

Conditions
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Xerostomia

Intervention / Treatment
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* Device: Electrical salivary stimulator system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Phase I: 8 subjects with xerostomia and 8 without that are 18 years old or older For Phase II: Subjects with xerostomia that are 18 years old or older Exclusion Criteria: For Phase I: Children and adolescents (persons under 18 years of age) Persons with experience in the use of SaliPen For Phase II: Subjects for them the study product is not indicated and/or do not agree to participate in Phase II. For the avoidance of doubt, the following conditions are exclusion criteria: Persons with experience in the use of SaliPen Children and adolescents (persons under 18 years of age) Epileptic disorder Persons that are allergic to the surface materials of the device Electrodes: coated with gold Body: made of methyl vinyl silicone rubber Use of a pacemaker Pregnancy Psychiatric or psychological disorders Involuntary muscle movement disorder (such as Parkinson's) Neurologic disorder in head and neck area

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single-center, prospective, open-label study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Factors<br>The primary objective of this research is to assess the human factors in relabeling the SaliPen from a prescription-based device to an OTC. Primary performance endpoints: The user can select the device properly. The user can use the device as instructed in the IFU. | Device: Electrical salivary stimulator system<br>* SaliPen is an electrical salivary stimulator system, intended to electrically stimulate a relative increase in saliva production. It is an intraoral device indicated for use in patients with xerostomia (dry mouth).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who appropriately will self-select the study product for use under simulated OTC conditions [Phase I] | Following the standard norms for the Rx-to-OTC switch process, this outcome is a validation of potential consumers' ability to self-diagnose the condition and to decide that treatment with the product is appropriate for them. | One hour | 
| Percentage of participants who correctly will use the study product when dispensed under simulated OTC conditions [Phase II]. | Correct use means that the participants will demonstrate the use of the study product according to the guidelines outlined in the User Manual. Following the standard norms for the therapy of Rx-to-OTC switch process, this outcome is a validation of potential consumers' ability to self-treat with the product according to the product's supplied IFU. | 1.5 hour |