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Comparison of Conventional With Sonography Assisted Breast Surgery

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.
 
ClinicalTrials.gov Identifier: NCT02840864
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
University Women's Hospital Tübingen

Brief 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

Condition or disease Intervention/treatment Phase
Breast Cancer Surgery Device: Sonography assisted breast surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Sonographically Assisted With Conventionally Breast Surgery - Prospective, Randomised, Multicenter, Parallel Group Study With Two Study Arms
Study Start Date : July 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
Sonographically assisted breast surgery
Device: Sonography assisted breast surgery
Active Comparator: Arm 2
Conventional breast surgery
Device: Sonography assisted breast surgery



Primary Outcome Measures :
  1. Rate of second tumor resections [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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): NCT02840864


Locations
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Germany
Department for Women's Health
Tübingen, Germany, 72076
Sponsors and Collaborators
University Women's Hospital Tübingen
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Responsible Party: University Women's Hospital Tübingen
ClinicalTrials.gov Identifier: NCT02840864    
Other Study ID Numbers: MAC-002
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No