AI analysis of electrosurgical smoke to detect cancer during breast-conserving surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The device is first trained in the lab to recognize gases released from cancerous versus normal breast tissue, then connected during surgery to sample electrosurgical smoke via a sterile hose to a smoke extractor. The AI will classify tissue in real time and its calls will be compared with rapid intraoperative biopsies and final histology to measure sensitivity, specificity, and accuracy. The trial will include multiple breast cancer subtypes to capture biological variability and the surgeries will be recorded for margin mapping. The device will undergo monthly calibration with known gases to maintain performance within a 5% variability threshold.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed diagnosis of malignant breast cancer
* Scheduled for BCS at the Hospital UC
* Able and willing to provide informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Patients with known hypersensitivity or allergy to any component of the BCGC device
* Participation in another interventional clinical trial within 30 days prior to enrolment

Where it's running

• Hospital Clínico UC CHRISTUS
  Santiago, Santiago Centro, Chile Recruiting
• Facultad de medicina UC
  Santiago, Santiago Metropolitan, Chile Active not recruiting

Study contacts

• Study coordinator: Maximiliano L Mariné
• Email: maxmarine@uc.cl
• Phone: +56952084996

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.