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NCT02222675 Clinical Trial

Conserving Breast Surgery - Comparison of Conventional With Sonography

Breast Surgery Clinical Trial

— MAC-001  

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 NCT02222675
Other study ID # MAC-001_1.1
Secondary ID
Status Completed
Phase N/A
First received August 20, 2014
Last updated April 12, 2017
Start date April 2009
Est. completion date May 2015

Study information
Verified date August 2014
Source University Women's Hospital Tübingen
Contact n/a
Is FDA regulated No
Health authority
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 46
Est. completion date May 2015
Est. primary completion date April 2015
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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Sonography assisted breast surgery

• Conventional breast surgery

Locations
Country Name City State
Germany University Women's Hospital 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 Five years
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