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Completed

NCT Number: NCT05058430

SaliPen Human Factors Study for OTC Labeling

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:

1. 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, 2. Phase II: aimed at assessing whether the users can use the study product correctly without counseling by a health care provider.

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Key information

Conditions

Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Dentistry, Oral Health Research Institute

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical salivary stimulator system assigned to subjects with xerostomia

Device

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).

No Electrical salivary stimulator system assigned to subjects without xerostomia

Device

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).

Primary outcomes

  1. Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I]

    Time frame: One hour

    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.

  2. Percentage of Participants Who Correctly Will Use the Study Product When Dispensed Under Simulated OTC Conditions [Phase II].

    Time frame: 1.5 hour

    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.

Sponsors and collaborators

Lead sponsor

Saliwell Ltd.

Industry

Collaborators

  • Indiana University

Registry information

Acronym: SaliPen

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2021
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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