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Feasibility and safety study of focused ultrasound surgery of breast fibroadenoma

Feasibility and safety study of focused ultrasound surgery of breast fibroadenoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050068
Enrollment
Unknown
Registered
2021-08-16
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Benign Tumor

Interventions

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 18-60 years; 2. Ultrasound diagnosis of lesions of BI-RADS grades 2-3, multiple single lesions are acceptable; 3. The pathological diagnosis of coarse needle aspiration was fibroadenoma; 4. Safe sound channel and the focus can reach the target area; 5. System ultrasound can display lesions; 6. The tumor is >= 5mm away from the skin.

Exclusion criteria

Exclusion criteria: 1. Pathological diagnosis of malignant disease 1; 2. There are malignant signs on imaging, BI-RADS grade 4-5; 3. KPS score 2 points; 4. The patient is pregnant or breastfeeding; 5. Past history of breast cancer; 6. There are foreign bodies implanted around the tumor; 7. Those with severe scars on the skin of the treatment area (protruding from the skin surface, with a width of >=1cm).

Design outcomes

Primary

MeasureTime frame
mean volume reduction;

Secondary

MeasureTime frame
complete ablation rate;

Countries

China

Contacts

Public ContactWang Shui

The First Affiliated Hospital of Nanjing Medical University

ws0801@hotmail.com+86 13701458115

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026