XerostomiaSaliPenNCT05058430
SaliPen Human Factors Study for OTC Labeling
A study testing Electrical salivary stimulator system assigned to subjects with xerostomia and No Electrical salivary stimulator system assigned to subjects without xerostomia in people with Xerostomia, run by Saliwell Ltd. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Xerostomia
- What is being tested?
- Electrical salivary stimulator system assigned to subjects with xerostomia and No Electrical salivary stimulator system assigned to subjects without xerostomia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to 18 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Dentistry, Oral Health Research Institute
Indianapolis, Indiana, 46202
About this study
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:
- 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,
- Phase II: aimed at assessing whether the users can use the study product correctly without counseling by a health care provider.
Read the detailed 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.
- Conditions
- Xerostomia
- Being tested
- Electrical salivary stimulator system assigned to subjects with xerostomia, No Electrical salivary stimulator system assigned to subjects without xerostomia
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical salivary stimulator system assigned to subjects with xerostomiaDevice
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 xerostomiaDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: No Electrical salivary stimulator system assigned to subjects without xerostomia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1.5 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start16 Sep 2021
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, open-label study.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saliwell Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Susan Zunt, DDS, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058430
- Sponsor's protocol ID
- IU12473
- Acronym
- SaliPen
- Status last verified
- Jun 2023
- First submitted
- 16 Sep 2021
- Last updated
- 9 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SaliPen Human Factors Study for OTC Labeling
- ClinicalTrials.gov ID
- NCT05058430
- Acronym / sponsor ID
- SaliPen / IU12473
- Conditions
- Xerostomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Saliwell Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Posted 9 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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,
- Phase II: aimed at assessing whether the users can use the study product correctly without counseling by a health care provider.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, prospective, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Subjects with xerostomia | Experimental | Device: Electrical salivary stimulator system assigned to subjects with xerostomiaThe 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. |
| Subjects without xerostomia | Active comparator | Device: No Electrical salivary stimulator system assigned to subjects without xerostomiaThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical salivary stimulator system assigned to subjects with xerostomiaSaliPen 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 | Subjects with xerostomia |
| No Electrical salivary stimulator system assigned to subjects without xerostomiaSaliPen 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 | Subjects without xerostomia |
Primary outcome
Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I]
Time frame: One hour
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.
Percentage of Participants Who Correctly Will Use the Study Product When Dispensed Under Simulated OTC Conditions [Phase II].
Time frame: 1.5 hour
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Zunt, DDS, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical salivary stimulator system assigned to subjects with xerostomia and No Electrical salivary stimulator system assigned to subjects without xerostomia in people with Xerostomia, run by Saliwell Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I] (time frame: One hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.