SaliPen Human Factors Study for OTC Labeling

Xerostomia Clinical Trial

— SaliPen  

Official title:

SaliPen Human Factors Study for OTC Labeling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058430
• Other study ID #: IU12473
• Status: Completed
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: November 18, 2021

Study information

• Verified date: June 2023
• Source: Saliwell Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Xerostomia

Intervention

Device:
• 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).
• 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).

Locations

Country	Name	City	State
United States	Indiana University School of Dentistry, Oral Health Research Institute	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Saliwell Ltd.	Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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