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SaliPen Human Factors Study for OTC Labeling
NCT05058430 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE Electrical salivary stimulator system assigned to subjects with xerostomia
- DEVICE No Electrical salivary stimulator system assigned to subjects without xerostomia
Study Locations (1)
Indiana
- Indiana University School of Dentistry, Oral Health Research Institute — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-09-16 |
| Est. Completion | 2021-11-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05058430
The ClinicalTrials.gov registry entry for NCT05058430 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Saliwell, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Xerostomia appearing as the primary indexed condition, and to 2 interventions — of which Electrical salivary stimulator system assigned to subjects with xerostomia is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05058430 reports 1 study location spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05058430 about?
NCT05058430 is a clinical study titled "SaliPen Human Factors Study for OTC Labeling". 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...
What is the current status of trial NCT05058430?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2021-09-16. Estimated completion is 2021-11-18.
What conditions does trial NCT05058430 study?
This clinical trial studies the following conditions: Xerostomia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05058430?
The interventions under investigation include: Electrical salivary stimulator system assigned to subjects with xerostomia (DEVICE), No Electrical salivary stimulator system assigned to subjects without xerostomia (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05058430?
This trial is sponsored by Saliwell, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05058430 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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