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

June 29, 2026 updated by: Valentina Hartwig, National Research Council, Institute of Clinical Physiology, Italy

ADisIRast: Applicazione Del Dispositivo NIR Nella Breast Unit. Studio Pilota Monocentrico, Non Randomizzato, Interventistico Con Dispositivo Medico, Premarket, Non Profit, Per la Valutazione Della Perfusione Del Lembo Cutaneo Pre e Post Operatoria

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ADISIRAST study is a single-center, non-randomized, pre-market, non-profit clinical investigation of a non-invasive near-infrared spectroscopy (NIRS) imaging device for the assessment of perfusion in mastectomy skin flaps in patients undergoing breast surgery with immediate reconstruction.

Mastectomy skin-flap viability is an important determinant of postoperative healing and reconstructive outcomes. In routine clinical practice, flap perfusion is mainly assessed through intraoperative inspection and surgical judgment. Objective methods for evaluating tissue oxygenation may provide complementary information and may help characterize regional perfusion patterns that are not readily apparent during standard clinical assessment.

Near-infrared spectroscopy is a non-invasive optical technique that estimates superficial tissue oxygen saturation (StO₂) by analyzing the relative absorption of near-infrared light by oxygenated and deoxygenated hemoglobin. The investigational device is a portable, non-contact NIRS imaging system that generates two-dimensional maps of superficial tissue oxygen saturation. The device does not require tissue contact, contrast-agent injection, or exposure to ionizing radiation. Acquisitions are performed by positioning the device at a standardized distance from the surgical area and obtaining a digital image together with the corresponding StO₂ map.

The study was designed to evaluate the feasibility, repeatability, and clinical interpretability of NIRS-derived StO₂ measurements in breast skin flaps throughout the perioperative period. NIRS images were acquired at predefined study time points, including a preoperative baseline assessment, an intraoperative assessment, and postoperative follow-up assessments(1 day and 15 days postoperative). This approach allowed the characterization of temporal changes in tissue oxygenation and the evaluation of regional differences within the skin flap.

Image analysis included assessment of absolute StO₂ values, regional oxygenation differences, spatial distribution of tissue areas within predefined StO₂ ranges, and longitudinal changes in oxygenation patterns. Regions of interest were defined within superior and inferior portions of the breast skin flap to explore regional perfusion heterogeneity. Additional image-derived metrics were calculated to quantify the extent of tissue area within selected StO₂ ranges and the degree of spatial heterogeneity of oxygenation.

Clinical and surgical data were prospectively collected, including reconstructive information, perioperative characteristics, postoperative flap healing, and clinically observed complications. NIRS findings were subsequently evaluated in relation to postoperative clinical observations, particularly the presence, location, and evolution of areas showing impaired healing or suspected ischemic changes.

Surgical planning and intraoperative decisions, including the choice of reconstructive approach, were made according to standard clinical practice, based on the treating surgical team's clinical assessment and preoperative evaluation. The operating surgeon was blinded to the intraoperative NIRS images, and NIRS findings did not influence surgical decision-making or the selection of the reconstructive procedure.

After study completion, NIRS-derived perfusion findings were retrospectively compared with the reconstructive strategy selected during surgery. This exploratory analysis was performed to assess the concordance between NIRS-based indications of flap perfusion and the clinical decision made by the surgical team. The analysis was intended to explore the potential future role of non-invasive tissue oxygenation imaging as an adjunctive tool for perioperative assessment and surgical training, rather than to evaluate a device-guided management strategy.

The study does not compare alternative surgical treatments or reconstructive techniques. It is designed as a feasibility and performance investigation and is not powered to establish definitive diagnostic thresholds, predict clinical outcomes with definitive accuracy, or demonstrate superiority of one reconstructive strategy over another. Data were collected prospectively and managed using coded participant identifiers.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56126
        • U.O. Senologia, Azienda Ospedaliero-Universitaria Pisana (AOUP) Presidio Ospedaliero Santa Chiara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Snapshot NIR Assessment

Each patient enrolled in the study will undergo the standard diagnostic and treatment process.

The only difference compared to patients not enrolled in the study will be the use of the experimental Snapshot NIR V3.0 device during the routine visits scheduled in any case, and in particular:

during the preoperative consultation between the plastic surgeon and the breast surgeon, which must take place within 30 days prior to surgery; during the pre- and post-operative phases; on the first post-operative day during hospitalization; and on the 15th (+/-5 days) post-operative day during one of the routinely scheduled dressing changes.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue Oxygen Saturation (StO₂) Measured by the Snapshot NIR V3.0 Device
Time Frame: Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
Superficial tissue oxygen saturation (StO₂, %) measured using the Snapshot NIR V3.0 imaging device. StO₂ values (%) will be obtained from predefined Regions of Interest (ROIs) identified on exported two-dimensional tissue oxygenation maps. Mean StO₂ (%) and the presence of hypoperfused areas will be evaluated at each scheduled study visit.
Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
Correlation Between Snapshot NIR Tissue Oxygen Saturation (StO₂) and Clinical Assessment of Breast Skin Flap Perfusion
Time Frame: Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
Correlation between superficial tissue oxygen saturation (StO₂, %) measured using the Snapshot NIR V3.0 device and the clinical assessment of breast skin flap perfusion performed by visual inspection. Clinical assessment findings and StO₂ measurements will be compared for the predefined Regions of Interest (ROIs). The outcome will be expressed as a correlation coefficient between StO₂ (%) measurements and the corresponding clinical assessment.
Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
Temporal Change in Tissue Oxygen Saturation (StO₂) of Breast Skin Flaps
Time Frame: Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
Change in superficial tissue oxygen saturation (StO₂, %) measured using the Snapshot NIR V3.0 device over time. Serial StO₂ measurements obtained from predefined Regions of Interest (ROIs) will be compared across study visits to evaluate the temporal evolution of tissue perfusion and hypoperfused areas.
Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Snapshot NIR Tissue Oxygen Saturation (StO₂) and Intraoperative Reconstructive Strategy
Time Frame: Intraoperative.
Correlation between tissue oxygen saturation (StO₂, %) measured using the Snapshot NIR V3.0 device and the intraoperative reconstructive strategy selected by the surgeon (prepectoral implant versus subpectoral tissue expander). The outcome will be expressed as the correlation between StO₂ (%) measurements and the selected reconstructive strategy.
Intraoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Council, Institute of Clinical Physiology, Italy

Investigators

  • Principal Investigator: Matteo Ghilli, MD, U.O. Senologia, Azienda Ospedaliero-Universitaria Pisana (AOUP)
  • Study Chair: Valentina Hartwig, PhD, National Research Council, Institute of Clinical Physiology, Italy
  • Study Director: Maria Giovanna Trivella, MD, National Research Council, Institute of Clinical Physiology, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Actual)

February 13, 2026

Study Completion (Actual)

February 13, 2026

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adisirast
  • IT-24-04-046716 (Other Identifier: European Database on Medical Devices (EUDAMED))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared because participants consented only to aggregated data publication and due to confidentiality and privacy constraints.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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