NCT07419113

Development of an Integrated Multi-channel Artificial Nose for Cancer Detection (UNos)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This interventional diagnostic study evaluated a multi-channel artificial nose (UNos) medical device for analysis of exhaled breath in participants with head and neck squamous cell carcinoma and healthy volunteers. Participants underwent a standardized breath sampling procedure, and exhaled air was analyzed using semi-selective sensor arrays to generate quantitative breath pattern signatures. The study evaluated the ability of the device to discriminate cancer participants from healthy controls based on sensor-derived breath profiles.

Detailed description

This prospective, non-randomized, interventional diagnostic study evaluated the performance of a multi-channel artificial nose (UNos) medical device for exhaled breath analysis in participants with head and neck squamous cell carcinoma and in healthy volunteers. Participants were assigned to one of two parallel groups: Adults with histologically confirmed squamous cell carcinoma of the head and neck. Healthy adult volunteers without known malignant disease. All participants underwent a standardized breath collection procedure according to the study protocol. Exhaled breath samples were collected into gas sampling bags under controlled conditions and subsequently analyzed using a multi-channel electronic nose system equipped with semi-selective chemical sensors designed to detect volatile organic compound-related signal patterns. The device generated quantitative sensor response values for each participant. These normalized sensor features were used for statistical classification modeling to distinguish cancer participants from healthy volunteers. Diagnostic performance was evaluated using receiver operating characteristic (ROC) curve analysis, including calculation of area under the curve (AUC), sensitivity, and specificity. The breath sampling and analysis procedure was non-invasive and did not influence clinical management. No therapeutic intervention was performed. Enrollment was completed with 45 participants.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	Artificial or Electronic Nose (E-Nose) medical device	medical device detecting breathe-out molecules

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2026-02-18
• Last updated: 2026-02-24

Locations

1 site across 1 country: Slovenia