Allergy Skin Prick Test ReadingNCT06743737
Digital Device Reading Skin Prick Test
An observational study of Allergy Skin Prick Test Reading, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Skin prick tests (SPTs), or intraepidermal tests, are the first diagnostic approach for people with a suspected allergy. SPTs are very simple, safe and quick. They are cheap tests and are very useful as a screening test for allergy, especially in diseases like bronchial asthma, rhinoconjunctivitis, food/drug allergy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy Skin Prick Test Reading
- What is being tested?
- Digital skin test reading device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: All patients with a food or aeroallergy who require a SPT in the routine allergy workup are invited to participate in the study.
Who may be able to join
- Patients who will undergo skin prick tests with panels of aeroallergens and/or foods.
- Over 18 years of age. The patient or their representative has given consent to participate in the study.
- The patient must not have taken an antihistamine in the last 5 days.
Who cannot join
- Patients who are evaluated by more than 40 prick tests. Patients who have taken an antihistamine within the previous 5 days. Patients who are being treated with antidepressants or other drugs with an antihistamine effect.
- Patients who suffer severe atopic dermatitis with forearm involvement. Patients with dermographism. Patients who are evaluated by intradermal testing. Pregnant women or women suspected to be pregnant. Vulnerable patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, Bern University Hospital, University of Bern
Bern, 3010
Lukas Jörg, +41 31 632 22 69, aip@insel.ch
About this study
Official title: Sensitivity and Specificity Study of Electromedical Device Nexkin DSPT and Manual Measurement of Hives in Allergy Skin Prick Tests
Skin prick tests (SPTs), or intraepidermal tests, are the first diagnostic approach for people with a suspected allergy. SPTs are very simple, safe and quick. They are cheap tests and are very useful as a screening test for allergy, especially in diseases like bronchial asthma, rhinoconjunctivitis, food/drug allergy and anaphylaxis. Together with the clinical history, SPTs allow to draw conclusions on allergies based on the sensitization pattern.
Nevertheless, the technique itself has evolved very little and continues to be performed entirely manually. This has a few drawbacks that limit the utility of the tests, in many cases limiting them to a purely qualitative assessment.
Read more
In comparison to standard practice (manual measurement), the digital skin test reading device Nexkin DSPT can provide the following benefits for project participants: Automates and digitizes the test reading, provides test results in digital format, reduces variability and subjectivity and greater consistency of diagnosis, reduces manual tasks allowing health professionals providing quantitative instead of qualitative results and avoiding potential human errors and allows a faster workflow, resulting in shorter patient visits.
The aim of this study is to validate the clinical utility of the electromedical skin test reading device Nexkin DSPT regarding its use in allergology clinics for the reading of skin prick allergy tests. The overall purpose of the study is to determine the sensitivity and specificity of skin prick tests (SPT) performed using the current practice of the fully manual SPT procedure and those performed using the Nexkin SPT DSPT (digital) procedure and to compare the sensitivity and specificity of both methods.
- Conditions
- Allergy Skin Prick Test Reading
- Being tested
- Digital skin test reading device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital skin test reading deviceDevice
The device to be studied measures optically the size of the wheals from skin tests (SPT) performed for the diagnosis of allergen sensitization.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the histamine (positive control) wheal by healthcare professional
Measured: At enrollment
Measurement of the NaCl (negative control) wheal by healthcare professional
Measured: At enrollment
Measurement of the histamine (positive control) wheal by digital device
Measured: At enrollment
Measurement of the NaCl (negative control) wheal by digital device
Measured: At enrollment
Secondary outcomes (1)
Measure of the time involved in the complete reading and recording of the results
Minutes and seconds of procedure (testing \& recording of results) will be recorded for both the manual procedure and the procedure using the digital device
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy Skin Prick Test ReadingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- sitem-insel AG Bern
- Responsible party
- Sponsor
- Investigators
- Elnaz Arjmand, Principal investigator, Inselspital, Bern / sitem-Insel AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743737
- Sponsor's protocol ID
- 2024-D0059
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity Study of Electromedical Device Nexkin DSPT and Manual Measurement of Hives in Allergy Skin Prick Tests
- ClinicalTrials.gov ID
- NCT06743737
- Acronym / sponsor ID
- 2024-D0059
- Conditions
- Allergy Skin Prick Test Reading
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- sitem-insel AG Bern
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Skin prick tests (SPTs), or intraepidermal tests, are the first diagnostic approach for people with a suspected allergy. SPTs are very simple, safe and quick. They are cheap tests and are very useful as a screening test for allergy, especially in diseases like bronchial asthma, rhinoconjunctivitis, food/drug allergy and anaphylaxis. Together with the clinical history, SPTs allow to draw conclusions on allergies based on the sensitization pattern.
Nevertheless, the technique itself has evolved very little and continues to be performed entirely manually. This has a few drawbacks that limit the utility of the tests, in many cases limiting them to a purely qualitative assessment.
In comparison to standard practice (manual measurement), the digital skin test reading device Nexkin DSPT can provide the following benefits for project participants: Automates and digitizes the test reading, provides test results in digital format, reduces variability and subjectivity and greater consistency of diagnosis, reduces manual tasks allowing health professionals providing quantitative instead of qualitative results and avoiding potential human errors and allows a faster workflow, resulting in shorter patient visits.
The aim of this study is to validate the clinical utility of the electromedical skin test reading device Nexkin DSPT regarding its use in allergology clinics for the reading of skin prick allergy tests. The overall purpose of the study is to determine the sensitivity and specificity of skin prick tests (SPT) performed using the current practice of the fully manual SPT procedure and those performed using the Nexkin SPT DSPT (digital) procedure and to compare the sensitivity and specificity of both methods.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with a food or aeroallergy who require a SPT in the routine allergy workup are invited to participate in the study.
Key inclusion criteria (3 listed)
- Patients who will undergo skin prick tests with panels of aeroallergens and/or foods.
- Over 18 years of age. The patient or their representative has given consent to participate in the study.
- The patient must not have taken an antihistamine in the last 5 days.
Key exclusion criteria (2 listed)
- Patients who are evaluated by more than 40 prick tests. Patients who have taken an antihistamine within the previous 5 days. Patients who are being treated with antidepressants or other drugs with an antihistamine effect.
- Patients who suffer severe atopic dermatitis with forearm involvement. Patients with dermographism. Patients who are evaluated by intradermal testing. Pregnant women or women suspected to be pregnant. Vulnerable patients
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 |
|---|---|---|
| Digital skin test reading deviceThe device to be studied measures optically the size of the wheals from skin tests (SPT) performed for the diagnosis of allergen sensitization. | Device | – |
Primary outcome
Measurement of the histamine (positive control) wheal by healthcare professional
Time frame: At enrollment
Measurement of the NaCl (negative control) wheal by healthcare professional
Time frame: At enrollment
Measurement of the histamine (positive control) wheal by digital device
Time frame: At enrollment
Measurement of the NaCl (negative control) wheal by digital device
Time frame: At enrollment
1 secondary outcome
Measure of the time involved in the complete reading and recording of the results
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Yes
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.
Inselspital, Bern University Hospital, University of Bern
Bern, Switzerland
Elnaz Arjmand principal investigator
Inselspital, Bern / sitem-Insel AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy Skin Prick Test Reading, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 20 Dec 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the histamine (positive control) wheal by healthcare professional (time frame: At enrollment). The study lists 4 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 20 Dec 2024.