Effect of Breast Implants om Mammography Screening

June 30, 2025 updated by: Vastra Gotaland Region
The purpose of the study is to survey how many women have breast implants in the mammography screening population and the effect of implants on the number and type of examinations and on costs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women participating in the mammography screening program in Gothenburg, Sweden.

Description

Inclusion Criteria:

  • Women participating in the mammography screening program.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women without breast implants
Women without breast implants participating in the mammography screening program.
Diagnostic test: Mammography screening
Breast screening mammograms use X-rays to look for cancers that are too small to see or feel.
Other Names:
  • Screening mammography
  • Mammogram screening
  • Breast screening
  • Screening mammogram
  • Breast cancer screening
Women with breast implants
Women with breast implants participating in the mammography screening program.
Diagnostic test: Mammography screening
Breast screening mammograms use X-rays to look for cancers that are too small to see or feel.
Other Names:
  • Screening mammography
  • Mammogram screening
  • Breast screening
  • Screening mammogram
  • Breast cancer screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Costs
Time Frame: 1 year post-operatively
Health economic analysis of the effects of implants on mammography screening
1 year post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence
Time Frame: 1 year
Prevalence of breast implants in a mammography screening population.
1 year
Frequency of need for additional examinations
Time Frame: 1 year
Survey of if breast implants infer extra examinations (mammography, ultrasounds, biopsies, diagnostic operations) in connection with screening mammography.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 23, 2022

First Submitted That Met QC Criteria

January 23, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01534

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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