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

NCT ID NCT07680296

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Oct 2024

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female sex, aged 18 to 90 years. * Breast cancer patients scheduled for mastectomy with immediate reconstruction using an implant or tissue expander; or healthy BRCA mutation carriers scheduled for prophylactic mastectomy. * No previous radiotherapy to the chest wall. * No previous neoadjuvant chemotherapy. Exclusion Criteria: * Severe psychiatric disorders. * Advanced malignancy. * Severe aortic stenosis. * Obstructive hypertrophic cardiomyopathy. * Severe chronic kidney disease. * Severe chronic obstructive pulmonary disease. * Uncontrolled diabetes mellitus. * Advanced peripheral arterial occlusive disease (Leriche-Fontaine class III). * Use of benzodiazepines, non-benzodiazepine hypnotics, typical or atypical antipsychotics, antidepressants, or anticonvulsants without a stable dose for at least 4 months. * Alcohol, caffeine, or other substance abuse. * Inability to reasonably adhere to study procedures. * Pregnancy or breastfeeding. * Concurrent participation in another clinical trial. * Withdrawal of informed consent.

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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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