NCT02840864

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 22, 2024

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

July 19, 2016

Last Update Submit

July 19, 2024

Conditions

Breast Cancer Surgery

Outcome Measures

Primary Outcomes (1)

  • Rate of second tumor resections

    2 years

Study Arms (2)

Arm 1

EXPERIMENTAL

Sonographically assisted breast surgery

Device: Sonography assisted breast surgery

Arm 2

ACTIVE COMPARATOR

Conventional breast surgery

Device: Sonography assisted breast surgery

Interventions

Sonography assisted breast surgeryDEVICE
Arm 1Arm 2

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 years
  • Female
  • Presurgical validated breast cancer

You may not qualify if:

  • Sonographically not defined report
  • Lobular breast cancer
  • Extensive ductal carcinoma in situ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Women's Health

Tübingen, 72076, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 21, 2016

Study Start

July 1, 2015

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

July 22, 2024

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)