Comparison of Conventional With Sonography Assisted Breast Surgery

NCT ID: NCT02840864

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Sonographically assisted breast surgery

Group Type EXPERIMENTAL

Sonography assisted breast surgery

Intervention Type DEVICE

Arm 2

Conventional breast surgery

Group Type ACTIVE_COMPARATOR

Sonography assisted breast surgery

Intervention Type DEVICE

Interventions

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Sonography assisted breast surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department for Women's Health

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MAC-002

Identifier Type: -

Identifier Source: org_study_id

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