Breast CancerADisIRastNCT07680296
NIR Device for Assessment of Skin Flap Perfusion in Breast Surgery: A Pilot Interventional Study
A study testing Snapshot NIR V3.0 in people with Breast Cancer and Breast Reconstruction, run by National Research Council, Institute of Clinical Physiology, Italy at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer, Breast Reconstruction, Mastectomy
- What is being tested?
- Snapshot NIR V3.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2024to 13 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe psychiatric disorders.
- Advanced malignancy.
- Severe aortic stenosis.
- Obstructive hypertrophic cardiomyopathy.
- Severe chronic kidney disease.
- Severe chronic obstructive pulmonary disease.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
U.O. Senologia, Azienda Ospedaliero-Universitaria Pisana (AOUP) Presidio Ospedaliero Santa Chiara
Pisa, 56126
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Breast Cancer, Breast Reconstruction, Mastectomy
- Being tested
- Snapshot NIR V3.0
- Keywords
- Near-Infrared Spectroscopy, Tissue Oxygenation, Skin Flap Perfusion, Breast Reconstruction, Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snapshot NIR V3.0Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Snapshot NIR Assessment | Experimental | 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. Receives: Device: Snapshot NIR V3.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Oxygen Saturation (StO₂) Measured by the Snapshot NIR V3.0 Device
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.
Measured: 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
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.
Measured: Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
Temporal Change in Tissue Oxygen Saturation (StO₂) of Breast Skin Flaps
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.
Measured: Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
Secondary outcomes (1)
Correlation Between Snapshot NIR Tissue Oxygen Saturation (StO₂) and Intraoperative Reconstructive Strategy
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.
Measured: Intraoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start10 Oct 2024
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Institute of Clinical Physiology, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Hartwig, National Research Council, Institute of Clinical Physiology, Italy
- Investigators
- Matteo Ghilli, MD, Principal investigator, U.O. Senologia, Azienda Ospedaliero-Universitaria Pisana (AOUP)Valentina Hartwig, PhD, Study chair, National Research Council, Institute of Clinical Physiology, ItalyMaria Giovanna Trivella, MD, Study director, National Research Council, Institute of Clinical Physiology, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680296
- Sponsor's protocol ID
- Adisirast
- Other IDs
- IT-24-04-046716
- Acronym
- ADisIRast
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because participants consented only to aggregated data publication and due to confidentiality and privacy constraints.
Publications
Trivella MG, Piersigilli A, Bernini F, Pelosi G, Burchielli S, Puzzuoli S, Kusmic C, L'Abbate A. Percutaneous cardiac support during myocardial infarction drastically reduces mortality: perspectives from a swine model. Int J Artif Organs. 2017 Jul 5;40(7):338-344. doi: 10.5301/ijao.5000604. Epub 2017 Jun 6.
PubMed 28604999Jalil B, Hartwig V, Moroni D, Salvetti O, Benassi A, Jalil Z, Pistoia L, Minutoli Tegrimi T, Quinones-Galvan A, Iervasi G, L'Abbate A, Guiducci L. A Pilot Study of Infrared Thermography Based Assessment of Local Skin Temperature Response in Overweight and Lean Women during Oral Glucose Tolerance Test. J Clin Med. 2019 Feb 19;8(2):260. doi: 10.3390/jcm8020260.
PubMed 30791407Hartwig V, Guiducci L, Marinelli M, Pistoia L, Tegrimi TM, Iervasi G, Quinones-Galvan A, L'Abbate A. Multimodal Imaging for the Detection of Brown Adipose Tissue Activation in Women: A Pilot Study Using NIRS and Infrared Thermography. J Healthc Eng. 2017;2017:5986452. doi: 10.1155/2017/5986452. Epub 2017 Sep 14.
PubMed 29104746Jalil B, Salvetti O, Poti L, Hartwig V, Marinelli M, L'Abbate A. Near infrared image processing to quantitate and visualize oxygen saturation during vascular occlusion. Comput Methods Programs Biomed. 2016 Apr;126:35-45. doi: 10.1016/j.cmpb.2015.12.001. Epub 2015 Dec 17.
PubMed 26725781Jalil B, Hartwig V, Salvetti O, Poti L, Gargani L, Barskova T, Matucci Cerinic M, L'Abbate A. Assessment of hand superficial oxygenation during ischemia/reperfusion in healthy subjects versus systemic sclerosis patients by 2D near infrared spectroscopic imaging. Comput Methods Programs Biomed. 2018 Mar;155:101-108. doi: 10.1016/j.cmpb.2017.12.006. Epub 2017 Dec 12.
PubMed 29512489Gargani L, Bruni C, Barskova T, Hartwig V, Marinelli M, Trivella MG, Matucci-Cerinic M, L'Abbate A. Near-infrared spectroscopic imaging of the whole hand: A new tool to assess tissue perfusion and peripheral microcirculation in scleroderma. Semin Arthritis Rheum. 2019 Apr;48(5):867-873. doi: 10.1016/j.semarthrit.2018.08.002. Epub 2018 Aug 11.
PubMed 30205980Longobardi P, Hartwig V, Santarella L, Hoxha K, Campos J, Laurino M, Salvo P, Trivella MG, Coceani F, Rocco M, L'Abbate A. Potential markers of healing from near infrared spectroscopy imaging of venous leg ulcer. A randomized controlled clinical trial comparing conventional with hyperbaric oxygen treatment. Wound Repair Regen. 2020 Nov;28(6):856-866. doi: 10.1111/wrr.12853. Epub 2020 Aug 24.
PubMed 32789935
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07680296
- Acronym / sponsor ID
- ADisIRast / Adisirast
- Conditions
- Breast Cancer, Breast Reconstruction, Mastectomy
- Keywords
- Near-Infrared Spectroscopy, Tissue Oxygenation, Skin Flap Perfusion, Breast Reconstruction, Mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Research Council, Institute of Clinical Physiology, ItalyUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Snapshot NIR Assessment | Experimental | Device: Snapshot NIR V3.0Each 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- Severe psychiatric disorders.
- Advanced malignancy.
- Severe aortic stenosis.
- Obstructive hypertrophic cardiomyopathy.
- Severe chronic kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snapshot NIR V3.0The 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. | Device | Snapshot NIR Assessment |
Primary outcome
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.
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.
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.
1 secondary outcome
Correlation Between Snapshot NIR Tissue Oxygen Saturation (StO₂) and Intraoperative Reconstructive Strategy
Time frame: Intraoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 28604999Trivella MG, Piersigilli A, Bernini F, Pelosi G, Burchielli S, Puzzuoli S, Kusmic C, L'Abbate A. Percutaneous cardiac support during myocardial infarction drastically reduces mortality: perspectives from a swine model. Int J Artif Organs. 2017 Jul 5;40(7):338-344. doi: 10.5301/ijao.5000604. Epub 2017 Jun 6.
- Background: PubMed 30791407Jalil B, Hartwig V, Moroni D, Salvetti O, Benassi A, Jalil Z, Pistoia L, Minutoli Tegrimi T, Quinones-Galvan A, Iervasi G, L'Abbate A, Guiducci L. A Pilot Study of Infrared Thermography Based Assessment of Local Skin Temperature Response in Overweight and Lean Women during Oral Glucose Tolerance Test. J Clin Med. 2019 Feb 19;8(2):260. doi: 10.3390/jcm8020260.
- Background: PubMed 29104746Hartwig V, Guiducci L, Marinelli M, Pistoia L, Tegrimi TM, Iervasi G, Quinones-Galvan A, L'Abbate A. Multimodal Imaging for the Detection of Brown Adipose Tissue Activation in Women: A Pilot Study Using NIRS and Infrared Thermography. J Healthc Eng. 2017;2017:5986452. doi: 10.1155/2017/5986452. Epub 2017 Sep 14.
- Background: PubMed 26725781Jalil B, Salvetti O, Poti L, Hartwig V, Marinelli M, L'Abbate A. Near infrared image processing to quantitate and visualize oxygen saturation during vascular occlusion. Comput Methods Programs Biomed. 2016 Apr;126:35-45. doi: 10.1016/j.cmpb.2015.12.001. Epub 2015 Dec 17.
- Background: PubMed 29512489Jalil B, Hartwig V, Salvetti O, Poti L, Gargani L, Barskova T, Matucci Cerinic M, L'Abbate A. Assessment of hand superficial oxygenation during ischemia/reperfusion in healthy subjects versus systemic sclerosis patients by 2D near infrared spectroscopic imaging. Comput Methods Programs Biomed. 2018 Mar;155:101-108. doi: 10.1016/j.cmpb.2017.12.006. Epub 2017 Dec 12.
- Background: PubMed 30205980Gargani L, Bruni C, Barskova T, Hartwig V, Marinelli M, Trivella MG, Matucci-Cerinic M, L'Abbate A. Near-infrared spectroscopic imaging of the whole hand: A new tool to assess tissue perfusion and peripheral microcirculation in scleroderma. Semin Arthritis Rheum. 2019 Apr;48(5):867-873. doi: 10.1016/j.semarthrit.2018.08.002. Epub 2018 Aug 11.
- Background: PubMed 32789935Longobardi P, Hartwig V, Santarella L, Hoxha K, Campos J, Laurino M, Salvo P, Trivella MG, Coceani F, Rocco M, L'Abbate A. Potential markers of healing from near infrared spectroscopy imaging of venous leg ulcer. A randomized controlled clinical trial comparing conventional with hyperbaric oxygen treatment. Wound Repair Regen. 2020 Nov;28(6):856-866. doi: 10.1111/wrr.12853. Epub 2020 Aug 24.
- Individual participant dataSharing planned: No. IPD will not be shared because participants consented only to aggregated data publication and due to confidentiality and privacy constraints.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Ghilli, MD principal investigator
U.O. Senologia, Azienda Ospedaliero-Universitaria Pisana (AOUP)
Valentina Hartwig, PhD study chair
National Research Council, Institute of Clinical Physiology, Italy
Maria Giovanna Trivella, MD study director
National Research Council, Institute of Clinical Physiology, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snapshot NIR V3.0 in people with Breast Cancer and Breast Reconstruction, run by National Research Council, Institute of Clinical Physiology, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07680296, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.