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Clinical study of ultrasound-guided vacuum-assisted breast biopsy system for en bloc excision of benign breast tumer

Clinical study of ultrasound-guided vacuum-assisted breast biopsy system for en bloc excision of benign breast tumer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063034
Enrollment
Unknown
Registered
2022-08-28
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

breast benign tumer

Interventions

None listed

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18-40 years; 2. Patients who are pathologically diagnosed as benign breast tumors and require surgical intervention; 3. The maximum diameter of the tumor is >= 2.0 cm and < 3.6 cm; 4. The tumor is located in the outer upper quadrant or lower quadrant; 5. The subjects voluntarily participated in the clinical trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant women; 2. Patients with a history of ipsilateral breast surgery; 3. Participated in clinical trials of other devices or drugs within one month; 4. The tumor is located in the nipple and areola area; 5. Bleeding tendency, coagulation dysfunction and related diseases; 6. Patients who cannot tolerate surgery or voluntarily give up surgery due to heart, brain, lung and other vital organ dysfunction; 7. The investigator thinks it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Postoperative cosmetic results and patient satisfaction evaluation;Postoperative pain score;

Countries

China

Contacts

Public ContactYinguang Gao

Beijing Friendship Hospital, Capital Medical University

gaoyinguang@gmail.com+86 13691099801

Outcome results

None listed

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