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Conserving Breast Surgery - Comparison of Conventional With Sonography (MAC-001)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02222675
First Posted: August 21, 2014
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Women's Hospital Tübingen
  Purpose
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

Condition Intervention
Breast Surgery Procedure: Sonography assisted breast surgery Procedure: Conventional breast surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Sonographically Assisted With Conventionally Breast Surgery - Prospective, Randomised, Multicenter, Parallel Group Study With Two Study Arms

Further study details as provided by University Women's Hospital Tübingen:

Primary Outcome Measures:
  • Rate of second tumor resections [ Time Frame: Five years ]

Enrollment: 46
Study Start Date: April 2009
Study Completion Date: May 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sonographically assisted breast surgery
Sonographically assisted breast surgery
Procedure: Sonography assisted breast surgery
Active Comparator: Conventional breast surgery
Conventional breast surgery
Procedure: Conventional breast surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222675


Locations
Germany
University Women's Hospital
Tübingen, Germany, 72076
Sponsors and Collaborators
University Women's Hospital Tübingen
  More Information

Responsible Party: University Women's Hospital Tübingen
ClinicalTrials.gov Identifier: NCT02222675     History of Changes
Other Study ID Numbers: MAC-001_1.1
First Submitted: August 20, 2014
First Posted: August 21, 2014
Last Update Posted: April 14, 2017
Last Verified: August 2014