Comparison of Conventional With Sonography Assisted Breast Surgery

University Hospital Tuebingen

Status: Completed

Conditions: Breast Cancer Surgery

Treatments: Device: Sonography assisted breast surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02840864

MAC-002

Details and patient eligibility

About

Aim of the study is to test whether surgical removal of a tumor under sonographic control as compared to conventional method reduces the rate of resections and local relapse

Enrollment: 374 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 70 years
• Female
• Presurgical validated breast cancer

Exclusion criteria

• Sonographically not defined report
• Lobular breast cancer
• Extensive ductal carcinoma in situ

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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374 participants in 2 patient groups

Arm 1

Experimental group

Description:

Sonographically assisted breast surgery

Treatment:

Device: Sonography assisted breast surgery

Arm 2

Active Comparator group

Description:

Conventional breast surgery

Treatment:

Device: Sonography assisted breast surgery