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Intraoperative Detection of Breast Cancer by Electrosurgical Gas Analysis and Artificial Intelligence

NCT07131735 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-08-20

No results posted yet for this study

Summary

The aim of this clinical trial is to assess the feasibility of training a device capable of distinguishing various gases emitted by tissues cauterized by an electrosurgical unit during a breast cancer resection surgery. The patients to be enrolled will be women over 18 years old diagnosed with breast cancer who are indicated for conservative breast cancer resection surgery as treatment.

The main questions to be answered are:

The specificity and sensitivity of the device in detecting margins compromised with tumor cells in resection surgeries.

Evaluate the applicability of the device in breast cancer surgeries for real-time detection of margins.

Evaluate the differences in the pattern of gases emitted in tumor cells vs normal cells.

By consenting, the study patients will allow the investigative team to access the clinical record, results of images, post-surgical biopsies, recording of the surgery while preserving the patient's anonymity, and the installation of the gas detection device. This device does not alter the flow of the surgery and does not add additional risk to it.

Conditions

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2025-09-18
Completion
2025-09-18

Countries

  • Chile

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07131735 on ClinicalTrials.gov