Clinical trial · Interventional
NIR Device for Assessment of Skin Flap Perfusion in Breast Surgery: A Pilot Interventional Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Reconstruction | — | UNRESOLVED | — |
| Mastectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Snapshot NIR V3.0 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Snapshot NIR Assessment
- description
- 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.
- interventionNames
- Device: Snapshot NIR V3.0
Primary outcomes (3)
- measure
- Tissue Oxygen Saturation (StO₂) Measured by the Snapshot NIR V3.0 Device
- timeFrame
- Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDTrivella 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. PMID 28604999
- BACKGROUNDJalil 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. PMID 30791407
- BACKGROUNDHartwig 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. PMID 29104746
- BACKGROUNDJalil 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. PMID 26725781
- BACKGROUNDJalil 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. PMID 29512489
- BACKGROUNDGargani 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.