Breast disease
Conditions
Interventions
Control group:Devicor Medical Products
Experimental group:vacuum-assisted mastectomy system (AT-VAB-I)
Sponsors
ACCUTARGET MEDIPHARMA(SHANGHAI)CO.LTD
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18 to 60 years old; 2. Those with single or multiple BI-RADS category 3~4A lesions with indications for surgery by imaging and with a maximum lesion diameter <= 3 cm; 3. Those who can understand the purpose of the trial, agree to participate in this clinical trial, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with skin diseases around the puncture site; 2. Those with unclear and ambiguous puncture paths; 3. Those with hematologic disorders such as bleeding tendency and coagulation mechanism disorders; 4. Those with combined serious cardiovascular (including but not limited to hypertension, diabetes with vascular sclerosis), liver, kidney, active infection, etc.; 5. Those with breast implants; 6. Those with breast hemangioma; 7. Those who have difficulty with pressure bandaging; 8. Those who have allergic reactions to local anesthetics; 9. Those with psychiatric disorders who are unable to give normal informed consent or normal treatment at a later stage; 10. Women during pregnancy or lactation; 11. Those who have participated in other clinical trials or are participating in a clinical trial within 1 month prior to screening. Others who are considered by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful completion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the experience of instrument use;Radiographic complete resection rate;Operation time;Surgical satisfaction; | — |
Countries
China
Contacts
Public ContactKejin Wu
Obstetrics & Gynecology Hospital of Fudan University
Outcome results
None listed