Understanding the Phenomena of Aging and Rupture of Breast Implants (CRIMA)

November 7, 2023 updated by: University Hospital, Strasbourg, France

Breast implants, like all implantable medical devices, are subject to wear and tear as they age in the body. In addition to this wear and tear, they are subject to external trauma, whether accidental during daily life, during insertion or during mammography.

The kinetics and mechanisms of aging are poorly studied and the phenomenon of implant rupture is not elucidated. However, studies of older generation implants have shown that implant rupture is correlated with the duration of implantation.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

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

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • laetitia RUFFENACH, MD
        • Sub-Investigator:
          • Frédéric BODIN, MD, PhD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Female adult (≥18 years old) operated on at the HUS for a change of breast prosthesis, aesthetic or reconstruction, between 2022 and 2024

Description

Inclusion criteria:

  • Female adult (≥18 years old)
  • operated on at the HUS for a change of breast prosthesis, aesthetic or reconstruction, between 2022 and 2024
  • having not expressed, after information, her opposition to participate in this research.

Exclusion criteria:

  • Women who have expressed their opposition to participating in the study
  • ruptured prosthesis, associated with a LAGC-AIM, excessive perspiration
  • interfering treatments and associated diseases, history

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mechanical properties of breast implants will be evaluated by uniaxial tensile tests
Time Frame: After extraction of breast implants
After extraction of breast implants

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: laetitia RUFFENACH, MD, Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France

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)

February 28, 2022

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8528

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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