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

NCT07419113 | Completed

• 1 other identifier: ORI2023-UNOS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; medical device

Outcome Measures

Primary Outcomes (1)

• Area Under the Receiver Operating Characteristic Curve (AUC) for Cancer Classification

  Area under the receiver operating characteristic (ROC) curve calculated from the artificial nose device classification model distinguishing participants with head and neck squamous cell carcinoma from healthy volunteers.

  At baseline visit

Secondary Outcomes (2)

• Sensitivity of Artificial Nose Device for Cancer Detection

  At baseline visit

• Specificity of Artificial Nose Device for Cancer Detection

  At baseline visit

Study Arms (2)

Head and Neck Cancer Participants - Breath Analysis

EXPERIMENTAL

Participants with histologically confirmed head and neck squamous cell carcinoma underwent a standardized exhaled breath sampling procedure according to study protocol. Breath samples were collected into gas sampling bags under controlled conditions and analyzed using a multi-channel artificial nose (UNos) medical device equipped with semi-selective chemical sensors. The device generated quantitative sensor response values representing volatile organic compound patterns in exhaled air. No therapeutic intervention was performed, and the procedure did not influence clinical management.

Device: Artificial or Electronic Nose (E-Nose) medical device

Healthy Volunteers - Breath Analysis

EXPERIMENTAL

Healthy adult volunteers underwent the same standardized exhaled breath sampling procedure as cancer participants. Breath samples were collected into gas sampling bags and analyzed using the multi-channel artificial nose (UNos) system to obtain quantitative sensor response patterns. The procedure was non-invasive and performed for diagnostic signal acquisition only, without any therapeutic intervention.

Device: Artificial or Electronic Nose (E-Nose) medical device

Interventions

Artificial or Electronic Nose (E-Nose) medical device DEVICE

medical device detecting breathe-out molecules

Head and Neck Cancer Participants - Breath Analysis; Healthy Volunteers - Breath Analysis

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers.
• Non-smokers and smokers
• Aged over 18 years.
• The person must be able to understand and sign the consent form for participation in the clinical trial ("informed consent").

You may not qualify if:

• Throat or pharyngeal cancer that is not squamous cell carcinoma
• Known malignant disease elsewhere in the body.
• Previously treated malignant disease anywhere in the body, with the exception of non-melanoma skin cancer or cervical CIS
• Diabetes.
• Age under 18 years.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Electronic Nose; Equipment and Supplies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Electrical Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 18, 2026
• Study Start: February 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)