SaliPen Human Factors Study for OTC Labeling

Saliwell

Status: Completed

Conditions: Xerostomia

Treatments: Device: Electrical salivary stimulator system assigned to subjects with xerostomia; Device: No Electrical salivary stimulator system assigned to subjects without xerostomia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05058430

IU12473

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Subjects with xerostomia

Experimental group

Description:

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.

Treatment:

Device: Electrical salivary stimulator system assigned to subjects with xerostomia

Subjects without xerostomia

Active Comparator group

Description:

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.

Treatment:

Device: No Electrical salivary stimulator system assigned to subjects without xerostomia