Comparison of Conventional With Sonography Assisted Breast Surgery

Breast Cancer Surgery Clinical Trial

Official title:

Comparison of Sonographically Assisted With Conventionally Breast Surgery - Prospective, Randomised, Multicenter, Parallel Group Study With Two Study Arms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840864
• Other study ID #: MAC-002
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2017
• Source: University Women's Hospital Tübingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: July 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Surgery

Intervention

Device:
• Sonography assisted breast surgery

Locations

Country	Name	City	State
Germany	Department for Women's Health	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Women's Hospital Tübingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of second tumor resections		2 years