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NIR Device for Assessment of Skin Flap Perfusion in Breast Surgery: A Pilot Interventional Study

NCT07680296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-02

No results posted yet for this study

Summary

The goal of this single-center, nonrandomized, interventional non-profit pilot study is to evaluate the feasibility and clinical utility of a non-invasive near-infrared spectroscopy (NIRS) imaging device for assessing skin-flap tissue oxygen saturation in adult women undergoing mastectomy and immediate breast reconstruction after oncological surgery.

The main questions it aims to answer are:

* Can NIRS imaging provide reproducible measurements of tissue oxygen saturation (StO₂) in mastectomy skin flaps before surgery, during the intraoperative phase, and during postoperative follow-up?
* Can spatial and temporal variations in StO₂ identify areas of potentially reduced flap perfusion or impaired tissue viability?
* Can NIRS-derived oxygenation measurements support the assessment of postoperative flap healing and ischemic complications?

Participants will:

* undergo non-invasive NIRS imaging of the breast skin flap before surgery;
* undergo one intraoperative NIRS acquisition during mastectomy and immediate breast reconstruction;
* undergo repeated NIRS imaging during postoperative follow-up visits;
* receive standard surgical treatment and postoperative care according to routine clinical practice.

NIRS imaging is performed for study purposes and does not influence intraoperative surgical decision-making or the choice of reconstructive procedure.

Conditions

Interventions

DEVICE

Snapshot NIR V3.0

The Snapshot NIR V3.0 device is used to noninvasively assess superficial breast skin flap tissue oxygenation and perfusion. NIR images and tissue oxygen saturation measurements are acquired preoperatively, early postoperatively, and at a later postoperative assessment.

Sponsors & Collaborators

  • National Research Council, Institute of Clinical Physiology, Italy

    lead OTHER

Principal Investigators

  • Matteo Ghilli, MD · U.O. Senologia, Azienda Ospedaliero-Universitaria Pisana (AOUP)

  • Valentina Hartwig, PhD · National Research Council, Institute of Clinical Physiology, Italy

  • Maria Giovanna Trivella, MD · National Research Council, Institute of Clinical Physiology, Italy

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2026-02-13
Completion
2026-02-13

Countries

  • Italy

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 NCT07680296 on ClinicalTrials.gov