Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universal Axon Clinical Research, LLC | UNKNOWN |
| Suthe Dermal | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This is a single-center, unblinded, prospective, cross-over study. The study population will include twenty (n=20) healthy subjects (10 men and 10 women) over the age of 18 with a self-reported fear/dislike of needles. Subjects who qualify for the study based on the study inclusion and exclusion criteria and who consent to participate in the study will undergo two (2) intramuscular (IM) injections in the deltoid muscle, two (2) subcutaneous (SC) injections in the abdomen, and two (2) fingersticks with a lancing device in the middle finger. One injection in each location will be performed using with no intervention (as per standard of care) and the other injection in each location will be performed using the DigiVibe device.
While the complete mechanisms of pain and pain diversion are not completely understood, DigiVibe locally targets the skin's pain receptors. Therefore, it is proposed that the vibrations from the DigiVibe device will counteract and/or lessen the pain around the injection site. This study will determine whether the use of DigiVibe during a procedure requiring injections provides greater reduction in pain than injections with no intervention (standard of care). This information will aid healthcare providers in selecting the best approach to management of pain in patients who must undergo injections that could cause pain and may benefit from additional pain reduction.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No DigiVibe | No Intervention | Standard of Care | |
| DigiVibe | Experimental | DigiVibe Vibration Anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DigiVibe Vibration Anesthesia | Device | DigiVibe Vibration Anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Visual Analogue Scale (VAS) Pain Scale | The original pain scores (Higher scores = worse pain) were represented by a grading scale of zero (0) to ten (10) on the VAS pain scale questionnaire. The mean in the values is represented by the mean of the original VAS scores without DigiVibe or with DigiVibe across all the participants and injection types. | 1 day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Chronic (daily) use of nonsteroidal anti-inflammatory drugs (NSAIDs) (i.e. ibuprofen, aspirin, naproxen, etc.), antiplatelet medications (i.e. clopidogrel, prasugrel, ticagrelor, cangrelor, cilostazol, etc), or anticoagulant medications (i.e. warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, heparin, enoxaparin, fondaparinux, etc.)
Chronic (daily) use of analgesics (i.e. acetaminophen, NSAIDs [ie. ibuprofen, naproxen], opioids [ie. morphine, oxycodone, fentanyl], lidocaine, cannabinoids [ie. CBD, THC],)
Any condition in the opinion of the study investigator that would potentially confound the results of this study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universal Axon Clinical Research, LLC | Doral | Florida | 33166 | United States |
Only IPD used in the results publication
May 15, 2025 through July 31, 2025
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | No DigiVibe (SOC), Then Digivibe | Participants received two rounds of injections with and without vibration anesthesia (DigiVibe) and completed Visual Analog Scale (VAS) pain scales immediately following the both rounds of injections. The first round of injections involved the Standard of Care (SOC) (injections without vibration anesthesia) with one subcutaneous abdomen (30G, 4mm needle with normal saline), one intramuscular deltoid (either 25G or 30G, 1 inch needles with normal saline), and one fingerstick (30G, 1.5 mm needle). After waiting 5 minutes, the DigVibe vibration anesthesia device was applied for 20 seconds (before and during lancing) and the second abdomen, deltoid, and fingerstick injections were administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Cross-Over Trial of males and females ≥ 18 years old who have a normal BMI of 18.5-29.9 kg/m2, and a self-reported fear/dislike of needles.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No DigiVibe (SOC), Then Digivibe | Participants received two rounds of injections with and without vibration anesthesia (DigiVibe) and completed Visual Analog Scale (VAS) pain scales immediately following the both rounds of injections. The first round of injections involved the Standard of Care (SOC) (injections without vibration anesthesia) with one subcutaneous abdomen (30G, 4mm needle with normal saline), one intramuscular deltoid (either 25G or 30G, 1 inch needles with normal saline), and one fingerstick (30G, 1.5 mm needle). After waiting 5 minutes, the DigVibe vibration anesthesia device was applied for 20 seconds (before and during lancing) and the second abdomen, deltoid, and fingerstick injections were administered. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age | Age of individuals who received injections without Digivibe and then with Digivibe |
| 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 | Mean Visual Analogue Scale (VAS) Pain Scale | The original pain scores (Higher scores = worse pain) were represented by a grading scale of zero (0) to ten (10) on the VAS pain scale questionnaire. The mean in the values is represented by the mean of the original VAS scores without DigiVibe or with DigiVibe across all the participants and injection types. | Pain scores of individuals who acted as their own control after receiving 6 total injections and completed a Visual Analog Scale (VAS) pain scales immediately following the both rounds of injections (no DigiVibe compared to injections with DigiVibe). | Posted | Mean | 95% Confidence Interval | Units on a scale | 1 day |
|
1 day
An adverse event (AE) is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a test article or in a clinical study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No DigiVibe (SOC), Then Digivibe | Participants received two rounds of injections with and without vibration anesthesia (DigiVibe) and completed Visual Analog Scale (VAS) pain scales immediately following the both rounds of injections. The first round of injections involved the Standard of Care (SOC) (injections without vibration anesthesia) with one subcutaneous abdomen (30G, 4mm needle with normal saline), one intramuscular deltoid (either 25G or 30G, 1 inch needles with normal saline), and one fingerstick (30G, 1.5 mm needle). After waiting 5 minutes, the DigVibe vibration anesthesia device was applied for 20 seconds (before and during lancing) and the second abdomen, deltoid, and fingerstick injections were administered. |
Not provided
Not provided
Lack of sham control and blinding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Goldfaden, PharmD, CCRP | East Coast Institute for Research at Universal Axon Clinical Research | 904-854-1354 | rg@roviaclinical.com |
Not provided
| 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 | May 4, 2025 | Oct 23, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Sex | Sex of individuals who received injections without Digivibe and then with Digivibe | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race | Race of individuals who received injections without Digivibe and then with Digivibe | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity | Ethnicity of individuals who received injections without Digivibe and then with Digivibe | Count of Participants | Participants |
|
| Height | Height | Height of individuals who received injections without Digivibe and then with Digivibe | Mean | Standard Deviation | Inches |
|
| Weight | Weight of individuals who received injections without Digivibe and then with Digivibe | Mean | Standard Deviation | Lbs |
|
| Body Mass Index (BMI) | BMI of individuals who received injections without Digivibe and then with Digivibe | Mean | Standard Deviation | kg/m2 |
|
| Systolic Blood Pressure (SBP) | SBP of individuals who received injections without Digivibe and then with Digivibe | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure (DBP) | DBP of individuals who received injections without Digivibe and then with Digivibe | Mean | Standard Deviation | mmHg |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
Not provided
Not provided
Not provided