Clinical trial · Interventional
A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection
A Clinical Investigation (Multicentric, Single Arm, Prospective, Stratified) to Confirm the Ability of MammoWave (Microwave Mammogram) in Breast Lesions Detection
- 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)
This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions. MammoWave is a innovative medical device, class IIa marked CE, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. Specifically MammoWave employs a novel technique wich generates images by processing very low power (\<1mW) microwave. The MammoWave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position. MammoWave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical investigation medical device class IIa marked CE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm
- description
- All patients perform standard breast screening and also MammoWave exam.
- interventionNames
- Device: Clinical investigation medical device class IIa marked CE
Primary outcomes (1)
- measure
- MammoWave sensitivity (number of 'true positive' results)
- timeFrame
- During the procedure
- description
- MammoWave sensitivity (number of 'true positive' results) compared to Reference Standard
Secondary outcomes (6)
- measure
- MammoWave specificity and sensitivity
- timeFrame
- During the baseline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed Informed consent Form * Women * Adult ≥ 18 years old * Having a radiologist study output obtained using mammography within the last month. Such radiologist study output may be integrated with ultrasound and /or magnetic resonance imaging output if deemed necessary by the responsible investigator and when available. The radiological output will be integrated with histological one if deemed necessary by the responsible investigator and when available. * Patients willing to comply with study protocol and recommendations Exclusion Criteria: * Patients who belong to any vulnerable group * Patients with implanted electronic devices * Patients who have undergone biopsy less than one week before MammoWave scan * Patients with nipple piercings (unless they are removed prior to examination) * Pregnancy or breastfeeding
References
Publications (1)
- DERIVEDAlvarez Sanchez-Bayuela D, Ghavami N, Romero Castellano C, Bigotti A, Badia M, Papini L, Raspa G, Palomba G, Ghavami M, Loretoni R, Calabrese M, Tagliafico A, Tiberi G. A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Confirm MammoWave's Ability in Breast Lesions Detection. Diagnostics (Basel). 2023 Jun 17;13(12):2100. doi: 10.3390/diagnostics13122100. PMID 37370995