Clinical Trials Directory

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UnknownNCT05914168

Clinical Data Collection in Breast Tomosynthesis (COBRIS)

Clinical Data Collection in Breast Tomosynthesis: COBRIS

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
GE Healthcare · Industry
Sex
Female
Age
35 Years
Healthy volunteers
Not accepted

Summary

The purpose of the study is to assess an image acquisition application for breast tomosynthesis in a clinical environment

Detailed description

After being informed about the study and potential risks, all patients giving written informed consent will undergo their routine mammography examination. One additional mammography view will be obtained with the investigational application and analyzed. Subject participation is expected to last no more than 30 minutes. After the mammography examination, subjects will be followed according to the hospital standard of care.

Conditions

Interventions

TypeNameDescription
DEVICEBreast TomosynthesisThree dimensional mammography

Timeline

Start date
2023-02-15
Primary completion
2024-02-01
Completion
2024-02-01
First posted
2023-06-22
Last updated
2023-06-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05914168. Inclusion in this directory is not an endorsement.