NCT05300464 A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection
| NCT ID | NCT05300464 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Umbria Bioengineering Technologies |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-01-07 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2023-01-07 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05300464 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05300464 currently recruiting?
Yes, NCT05300464 is actively recruiting participants. Contact the research team at gianluigi@ubt-tech.com for enrollment information.
Where is the NCT05300464 trial being conducted?
This trial is being conducted at Genova, Italy, Foligno, Italy, Trieste, Italy, Toledo, Spain.
Who is sponsoring the NCT05300464 clinical trial?
NCT05300464 is sponsored by Umbria Bioengineering Technologies. The trial plans to enroll 600 participants.
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