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SaliPen Human Factors Study for OTC Labeling

NCT05058430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-01-09

Study results available
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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.

Conditions

  • Xerostomia

Interventions

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).

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).

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • Saliwell Ltd.

    lead INDUSTRY

Principal Investigators

  • Susan Zunt, DDS, MS · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2021-11-18
Completion
2021-11-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05058430 on ClinicalTrials.gov