Healthy Adult ParticipantsNCT07758777
Usability Evaluation of the Intelligent Fingerprinting Drug Screening System
A study testing Diagnostic procedures and Drug Screening in people with Healthy Adult Participants, run by Intelligent Bio Solutions Inc. at 1 site in United States.
Trial summary
This is a prospective performance evaluation of usability of the Intelligent Fingerprinting Drug Screening System, conducted in clinic. The total number of healthy adult subjects (male and female) required for enrollment in this study protocol is 45: 15 operators and 30 donors (ideally two donors assigned to one… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Diagnostic procedures and Drug Screening
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to 24 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed of the nature of the study, agreed to, and able to read, review, and sign the informed consent document prior to dosing. The informed consent document will be written in English; therefore, the subject must have the ability to read and communicate in English.
- Completed the screening process within 30 days prior to enrollment. Subjects screened as a part of an IRB-approved General Screening Protocol at the clinical research site may be included in this study without additional screening procedures provided all the required screening procedures have been performed within 30 days prior to enrollment.
Who cannot join
- Is not able to read and communicate in English.
- If, in the opinion of the Investigator, the subject is not suitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability Evaluation of the Intelligent Fingerprinting(TM) Drug Screening System
This is a prospective performance evaluation of usability of the Intelligent Fingerprinting Drug Screening System, conducted in clinic. The total number of healthy adult subjects (male and female) required for enrollment in this study protocol is 45: 15 operators and 30 donors (ideally two donors assigned to one operator). The total duration of the study, from check-in through the end of the study will be 2-4 hours for each donor subject.
Read the detailed description
15 adults, aged 18 to 65, male and female subjects. Each subject receives virtual training in the use of the Intelligent Fingerprinting Drug Testing System. Upon completion of training, each operator tests at least two (2) donors.
Thirty (30) additional subjects are recruited as donors. Donors provide fingerprint sweat specimens as instructed by operators.
For the 15 operator subjects, the in-clinic portion of the study will be four (4) to eight (8) hours. Operators will complete a combination virtual and hands-on training session. Upon completion of the training session, each operator subject will use the Intelligent Fingerprinting Drug Testing System to test two donor subjects. For one of the donor subjects, the screening cartridge will be coded to yield a non-negative result. This will prompt the operator subject to follow a different sequence of steps. The ability of the operator subject to use the system properly will be assessed by quantitative criteria.
- Conditions
- Healthy Adult Participants
- Being tested
- Diagnostic procedures, Drug Screening
- Keywords
- Observational, Usability, IVD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic proceduresDiagnostic test
Training in the use of the Intelligent Fingerprinting Drug Screening System.
Drug ScreeningDevice
Screening for drug use
| Study group | Role | What they receive |
|---|---|---|
| Operators | Experimental | "Operators" represent end users who utilize the screening system in an office or work setting. These subjects must have a minimum of high school education or equivalent. They do not have to possess special training in laboratory methods or medicine. No more than two-thirds (10 of 15) of operator subjects may be of the same sex (male or female). Operators will be trained in the use of the medical device. Receives: Diagnostic Test: Diagnostic procedures |
| Donors | Sham comparator | "Donors" represent end users either applying for employment or working at an organization that conducts pre-employment and/or periodic workplace drug screening. Donors could include office workers, healthcare workers, technology professionals, train engineers, bus drivers, pilots, construction workers, truck drivers, manufacturing employees, food service workers, and equipment operators. No more than two-thirds (20 of 30) of donor subjects may be of the same sex (male or female). Donors will be tested with the IVD medical devices. Results will be contrived. Receives: Device: Drug Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator Testing
Usability testing of 15 operators, with training effectiveness assessed via 20 conformity to 20-task procedure.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start20 Jul 2026
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intelligent Bio Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elan Cohen, PhD, Principal investigator, CenExel HRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758777
- Sponsor's protocol ID
- IBS-2026-01
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data is unique to Sponsor's proprietary device.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Evaluation of the Intelligent Fingerprinting(TM) Drug Screening System
- ClinicalTrials.gov ID
- NCT07758777
- Acronym / sponsor ID
- IBS-2026-01
- Conditions
- Healthy Adult Participants
- Keywords
- Observational, Usability, IVD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Intelligent Bio Solutions Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 11 Aug 2026 (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.
This is a prospective performance evaluation of usability of the Intelligent Fingerprinting Drug Screening System, conducted in clinic. The total number of healthy adult subjects (male and female) required for enrollment in this study protocol is 45: 15 operators and 30 donors (ideally two donors assigned to one operator). The total duration of the study, from check-in through the end of the study will be 2-4 hours for each donor subject.
Detailed description
15 adults, aged 18 to 65, male and female subjects. Each subject receives virtual training in the use of the Intelligent Fingerprinting Drug Testing System. Upon completion of training, each operator tests at least two (2) donors.
Thirty (30) additional subjects are recruited as donors. Donors provide fingerprint sweat specimens as instructed by operators.
For the 15 operator subjects, the in-clinic portion of the study will be four (4) to eight (8) hours. Operators will complete a combination virtual and hands-on training session. Upon completion of the training session, each operator subject will use the Intelligent Fingerprinting Drug Testing System to test two donor subjects. For one of the donor subjects, the screening cartridge will be coded to yield a non-negative result. This will prompt the operator subject to follow a different sequence of steps. The ability of the operator subject to use the system properly will be assessed by quantitative criteria.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operators | Experimental | Diagnostic Test: Diagnostic procedures"Operators" represent end users who utilize the screening system in an office or work setting. These subjects must have a minimum of high school education or equivalent. They do not have to possess special training in laboratory methods or medicine. No more than two-thirds (10 of 15) of operator subjects may be of the same sex (male or female). Operators will be trained in the use of the medical device. |
| Donors | Sham comparator | Device: Drug Screening"Donors" represent end users either applying for employment or working at an organization that conducts pre-employment and/or periodic workplace drug screening. Donors could include office workers, healthcare workers, technology professionals, train engineers, bus drivers, pilots, construction workers, truck drivers, manufacturing employees, food service workers, and equipment operators. No more than two-thirds (20 of 30) of donor subjects may be of the same sex (male or female). Donors will be tested with the IVD medical devices. Results will be contrived. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed of the nature of the study, agreed to, and able to read, review, and sign the informed consent document prior to dosing. The informed consent document will be written in English; therefore, the subject must have the ability to read and communicate in English.
- Completed the screening process within 30 days prior to enrollment. Subjects screened as a part of an IRB-approved General Screening Protocol at the clinical research site may be included in this study without additional screening procedures provided all the required screening procedures have been performed within 30 days prior to enrollment.
Key exclusion criteria (2 listed)
- Is not able to read and communicate in English.
- If, in the opinion of the Investigator, the subject is not suitable for the study.
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 |
|---|---|---|
| Diagnostic proceduresTraining in the use of the Intelligent Fingerprinting Drug Screening System. | Diagnostic test | Operators |
| Drug ScreeningScreening for drug use | Device | Donors |
Primary outcome
Operator Testing
Time frame: 1 week
Usability testing of 15 operators, with training effectiveness assessed via 20 conformity to 20-task procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. Study data is unique to Sponsor's proprietary device.
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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.
Elan Cohen, PhD principal investigator
CenExel HRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic procedures and Drug Screening in people with Healthy Adult Participants, run by Intelligent Bio Solutions Inc. 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 2 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: finished, as of the sponsor's last update on 11 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Operator Testing (time frame: 1 week). 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 11 Aug 2026.