Clinical trial · Interventional
Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection
A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Evaluate the Ability of MammoWave 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 using Mammowave that is a device, which uses microwaves instead of ionizing radiation (X-ray)for breast lesions(BL) detection. Specifically, Mammowave employs a novel technique which generates images by processing very low power (\<1 mW) microwaves. The exam takes few minutes per breast and is performed with the patient lying in a comfortable 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 device class IIa not 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 device class IIa not 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 (against Reference Standard)
- timeFrame
- During the baseline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed Informed consent Form 2. Women 3. Adult ≥18 years old 4. Having a radiologist study output obtained using conventional exams (such as breast specialist visit and mammography and/or ultrasound and/or magnetic resonance imaging) within the last month. 5. Patients willing to comply with study protocol and recommendations. 6. Patients with intact breast skin (i.e. without bleeding lesion, scar). Exclusion Criteria: 1. Patients that are enrolled in another clinical study 2. Patients who belong to any vulnerable group. 3. Patients with implanted electronics. 4. Patients who have undergone biopsy less than one week before MammoWave scan 5. Patients with breast implants 6. Patients with nipple piercings (unless they are removed before MammoWave exam). 7. Participation in other studies in the last month before screening 8. Pregnancy or breastfeeding
References
Publications (0)
Data not yet available