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| Name | Class |
|---|---|
| Indiana University | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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
Use of a pacemaker
Pregnancy
Psychiatric or psychological disorders
Involuntary muscle movement disorder (such as Parkinson's)
Neurologic disorder in head and neck area
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| Name | Affiliation | Role |
|---|---|---|
| Susan Zunt, DDS, MS | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Dentistry, Oral Health Research Institute | Indianapolis | Indiana | 46202 | United States |
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Period 1 was devoted to Phase I that included 8 subjects with and 8 without xerostomia.
Period 2 was devoted to Phase II that included 16 subjects with xerostomia. Eight of those participated previously in Phase II.
Patients visiting the participating clinic were asked to participate in the study sequentially (by order of recall or arrival at the clinic).
For Phase I, enrollment was stopped once the goal of eight (8) subjects with xerostomia and eight (8) subjects without xerostomia has been reached.
For Phase II, 16 subjects with xerostomia that were evaluated or treated at the clinic were enrolled sequentially (by order of recall or arrival at the clinic).
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Xerostomia | Subjects complaining of xerostomia |
| FG001 | Subjects Without Xerostomia | Subjects not complaining of xerostomia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Selection of the SaliPen Device |
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| Use of the SaliPen Device |
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In Phase I: Eight (8) 'All Comers' to an oral health clinic with no xerostomia and eight (8) patients with xerostomia.
In Phase II: Sixteen (16) xerostomia patients (eight (8) of them participated in Phase I).
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| ID | Title | Description |
|---|---|---|
| BG000 | Selection and/or Use of the SaliPen Device by Subjects With or Without Xerostomia | Phase I Subjects with and without xerostomia were 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 was dispensed only to subjects with xerostomia. They were requested to use it with no training, except for their understanding of the User Manual (internal labeling). Those subjects used the study product in a supervised clinical setting. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Eight subjects with xerostomia and 8 subjects without xerostomia | Posted | Number | percentage | One hour |
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1 month
The examiners observed the occurrence of any adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I: Selection of the SaliPen Device by Subjects With or Without Xerostomia | Subjects with and without xerostomia were 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andy Wolff | Saliwell Ltd. | +972508801852 | awolff@saliwell.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2021 | May 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2021 | May 5, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Single-center, prospective, open-label study.
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|
| 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). |
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| NOT COMPLETED |
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| Count of Participants |
| Participants |
| No |
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| Age, Continuous | The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases. | Mean | Full Range | years |
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| Sex: Female, Male | The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases. | Count of Participants | Participants |
|
| Xerostomia status based on self-report (suffering or not from xerostomia) | Xerostomia status was determined through self-report. Subjects attending the clinic were asked whether they suffer or not from xerostomia. According to their answer, they were allocated to each group: subjects with xerostomia or subjects without xerostomia. | Overall participant number was 24. 8 (with no xerostomia) participated only in Phase I . 8 (with xerostomia) participated only in Phase II. 8 (with xerostomia) participated in both, Phase I and Phase II. | Count of Participants | Participants |
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| Participants |
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| Primary | 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. | All patients suffered from xerostomia | Posted | Number | percentage | 1.5 hour |
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|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Phase II: Use of the SaliPen Device by Subjects With Xerostomia | The study product was dispensed only to subjects with xerostomia. They were requested to use it with no training, except for their understanding of the User Manual (internal labeling). Those subjects used the study product in a supervised clinical setting. | 0 | 16 | 0 | 16 | 0 | 16 |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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