Usability Evaluation of the Intelligent Fingerprinting Drug Screening System

NCT07758777 | Completed

• 1 other identifier: IBS-2026-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy Adult Participants

Keywords

Observational; Usability; IVD

Outcome Measures

Primary Outcomes (1)

• Operator Testing

  Usability testing of 15 operators, with training effectiveness assessed via 20 conformity to 20-task procedure.

  1 week

Study Arms (2)

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.

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.

Device: Drug Screening

Interventions

Diagnostic procedures DIAGNOSTIC_TEST

Training in the use of the Intelligent Fingerprinting Drug Screening System.

Operators

Drug Screening DEVICE

Screening for drug use

Donors

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Is not able to read and communicate in English.
• If, in the opinion of the Investigator, the subject is not suitable for the study.

Sponsors & Collaborators

• Intelligent Bio Solutions Inc.: lead

Study Sites (1)

CenExel HRI

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Interventions

Diagnostic Techniques and Procedures; Drug Evaluation, Preclinical

Intervention Hierarchy (Ancestors)

Diagnosis; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Elan Cohen, PhD

  CenExel HRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 11, 2026
• Study Start: July 20, 2026
• Primary Completion: July 24, 2026
• Study Completion: July 24, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)