N/A N=16 Randomized Other

SaliPen Human Factors Study for OTC Labeling

Xerostomia

Bottom Line

View on ClinicalTrials.gov: NCT05058430 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I] — 100; 100 percentage

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Electrical salivary stimulator system assigned to subjects with xerostomia (Device); No Electrical salivary stimulator system assigned to subjects without xerostomia (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Saliwell Ltd.
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I]	100; 100	—
PRIMARY Percentage of Participants Who Correctly Will Use the Study Product When Dispensed Under Simulated OTC Conditions [Phase II].	100; 100	—

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.

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05058430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.