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| Name | Class |
|---|---|
| Georgia Institute of Technology | OTHER |
| The Consortium for Technology & Innovation in Pediatrics (CTIP) | UNKNOWN |
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This study is being done to test a device called micro Sweat Test Patch (mSTP or µSTP).
The study team will compare the standard of care (SOC) method of sweat testing with a novel sweat test technique using an integrated micro Sweat Test Patch (µSTP) with microneedle assembly made out of Pilocarpine nitrate, microfluidic channels, and a chloride sensor for point-of-care (POC) measurements of sweat chloride concentrations in newborns being evaluated for cystic fibrosis (CF) diagnosis and in pediatric and adult people with CF (pwCF).
The procedures involve performing a SOC sweat test (if they are not a neonate) and the novel sweat test developed by the research team.
Recruitment for the study will take place at Children's Healthcare of Atlanta and Emory Healthcare cystic fibrosis clinics.
The current SOC sweat testing method, using pilocarpine iontophoresis and Macroduct collectors, results in inconsistent sweat production, leading to inadequate collection, delays in CF diagnosis, longer testing times, skin discomfort, and a risk of skin burns. It requires trained personnel and expensive equipment, limiting patient access, and repeating sweat tests after inadequate collection causes delays in starting therapies and stress for parents. In developing countries where CF remains underdiagnosed, access to sweat testing is a major barrier, and the need for refrigeration of the pilogel discs adds cost.
There is an unmet clinical need to improve access to sweat testing worldwide without expensive supplies and laboratory equipment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sweat testing using the standard of care | Active Comparator | For the SOC method, the forearm will be cleaned with alcohol and then cleaned with deionized (DI) water. The study team will then place two pilocarpine gel discs into the corresponding electrodes and place them on the subject's arm. The SOC method takes 5 minutes to induce sweating using iontophoresis. After sweat has been induced by the SOC method, a sweat collector will be placed on the location of the red electrode to collect the sweat. At the end of the sweat collection period, the sweat collection device will be removed, and the sweat will be extracted from the collection device for analysis in the clinical lab using a chloridometer. |
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| Novel sweat test method | Experimental | Participants will have the micro Sweat Test Patch (µSTP) placed on the forearm after cleaning with an alcohol pad for 20 minutes. After the stimulation phase, the collection of sweat will be automatically collected by the microfluidics channel on the µSTP, and the sensor will continuously read the sweat chloride value. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micro Sweat Test Patch (mSTP) | Device | A novel sweat test method, using a device that includes a microneedle pilocarpine patch and a microchannel with a sweat chloride sensor. µSTP sweat testing device that operates without electrical current, eliminating the risk of burns and the need for specialized equipment. Like the SOC method, the µSTP stimulates sweating with pilocarpine nitrate and measures sweat chloride concentration but differs from the current method by:
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| Measure | Description | Time Frame |
|---|---|---|
| Sweat Chloride Concentration using the sweat test sensor | Sweat chloride concentration by the µSTP will be assessed and measured using the sweat test sensor. | up to 30 minutes post-device placement |
| Sweat Chloride Concentration by SOC | Sweat chloride concentrations will be measured using the standard-of-care method, using pilocarpine iontophoresis. The collected sweat samples will be sent for analysis of the chloride concentration. The results from the same participant will be compared to the measurements made with the µSTP device. | up to 45 minutes post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Erythema Assessment Scale | The µSTP application site will be photographed after patch removal, and the degree of skin erythema at the site of µSTP application will be scored by the study team member using the Visual Erythema Assessment Scale. The Visual Erythema Assessment Scale ranges from 0 (clear/no erythema) to 9 (severe/intense redness). 1-2: Trace/Very Mild - Barely perceptible redness; may require side-by-side comparison with unaffected skin to detect. 3-4: Mild/Faint - Distinct pinkness but lacks sharp borders; usually described as a "healthy glow" in facial assessments. 5-6: Moderate - Clear, definite redness that is easily recognized across a room; skin may begin to feel warm. 7-8: Severe/Bright - Intense, fiery red coloration; often accompanied by localized swelling (edema) or heat. 9: Very Severe - Deep purple or "beet-red" intensity; may involve blistering, skin erosion, or extreme tenderness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lokesh Guglani, MD | Contact | 404-785-7856 | lokesh.guglani@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lokesh Guglani, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adult Cystic Fibrosis Clinic | Atlanta | Georgia | 30324 | United States | ||
| Arthur M. Blank Hospital | Children's Healthcare of Atlanta |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Sweat Testing using SOC | Diagnostic Test | The study team will place two pilocarpine gel discs into the corresponding electrodes and place them on the participant's arm. The SOC method takes 5 minutes to induce sweating. After sweat has been induced by the SOC method, a sweat collector will be placed on the location of the red electrode to collect the sweat. At the end of the sweat collection period, the sweat collection device will be removed, and the study visit will be completed. For newborns undergoing evaluation for CF, the study team will perform the µSTP method on their thigh instead of the forearm. Since newborns will undergo sweat testing for their clinical diagnosis, the study team will use the sweat data from SOC testing to minimize burden. The sweat chloride concentration will be assessed by a laboratory chloridometer. |
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| Immediately after patch removal |
| Pain Score | Pain Score will be assessed using either the Wong-Baker FACES® Pain Rating Scale or the numeric pain rating scale (NPRS). Both instruments use a 0 to 10 rating range. The Wong-Baker FACES® Pain Rating Scale is a validated tool used to help individuals (typically ages 3 years and older) communicate their level of pain by selecting one from six faces representing increasing pain intensity. The scale corresponds to values from 0 ("no hurt") to 10 ("hurts worst"), with higher values indicating greater pain. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which participants select an integer from 0 to 10 that best reflects the intensity of their pain. A score of '0' indicates "no pain", and a score of '10' represents the "worst pain imaginable". For both scales, scores range from 0 to 10, with higher scores indicating greater pain intensity. | Up to 2 hours post-intervention |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |