SaliPen Human Factors Study for OTC Labeling

NCT ID: NCT05058430

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2021-11-18

Brief Summary

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.

Detailed 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.

Conditions

Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Subjects with xerostomia

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.

Group Type: EXPERIMENTAL

Electrical salivary stimulator system assigned to subjects with xerostomia

Intervention Type: 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).

Subjects without xerostomia

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.

Group Type: ACTIVE_COMPARATOR

No Electrical salivary stimulator system assigned to subjects without xerostomia

Intervention Type: 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).

Interventions

Electrical salivary stimulator system assigned to subjects with xerostomia

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).

Intervention Type: DEVICE

No Electrical salivary stimulator system assigned to subjects without xerostomia

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: collaborator

Saliwell Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Zunt, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University School of Dentistry, Oral Health Research Institute

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IU12473

Identifier Type: -

Identifier Source: org_study_id