New Light-Based device could spot troubled skin flaps after breast surgery

NCT ID NCT07680296

Completed Knowledge-focused Sponsor: National Research Council, Institute of Clinical Physiology, Italy Source: ClinicalTrials.gov ↗

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This pilot study tests a near-infrared (NIR) imaging device that measures oxygen levels in breast skin flaps during and after mastectomy with immediate reconstruction. The goal is to see if the device can reliably detect areas with poor blood flow that might lead to healing problems. Twenty women scheduled for mastectomy will have NIR scans before, during, and after surgery, while receiving standard care. The device is experimental and does not change how surgeons operate.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Snapshot NIR V3.0 device
What this could lead to: If successful, this device could help surgeons identify poorly perfused skin flaps early, potentially reducing complications after breast reconstruction.
What could go wrong: This is a small pilot study with only 20 participants, so results may not apply to all patients. The device is not yet approved and does not guide surgical decisions during the trial.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST CANCER BREAST RECONSTRUCTION MASTECTOMY

Contacts and locations

Locations

U.O. Senologia, Azienda Ospedaliero-Universitaria Pisana (AOUP) Presidio Ospedaliero Santa Chiara

Pisa, 56126, Italy

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