SaliPen Human Factors Study for OTC Labeling

NCT05058430 | Completed Results FDA Device

• 1 other identifier: IU12473
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Subjects with xerostomia

EXPERIMENTAL

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 assigned to subjects with xerostomia

Subjects without xerostomia

ACTIVE COMPARATOR

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.

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

Interventions

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).

Subjects with xerostomia

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).

Subjects without xerostomia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saliwell Ltd.: lead
• Indiana University: collaborator

Study Sites (1)

Indiana University School of Dentistry, Oral Health Research Institute

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Andy Wolff
• Organization: Saliwell Ltd.

awolff@saliwell.com

+972508801852

Study Officials

• Susan Zunt, DDS, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, open-label study.

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: September 16, 2021
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)