Aging of Breast ImplantsCRIMANCT05527132
Understanding the Phenomena of Aging and Rupture of Breast Implants
An observational study of Aging of Breast Implants, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Aging of Breast Implants
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2022to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France
Strasbourg, 67091
laetitia RUFFENACH, MD, 33 3 68 76 51 67, laetitia.ruffenach@chru-strasbourg.fr
laetitia RUFFENACH, MD
About this study
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.
- Conditions
- Aging of Breast Implants
- Keywords
- Breast Prosthesis Implantation, Aging of breast implants, Rupture of breast implants
What is being measured
The primary outcome is the main question the study is designed to answer.
The mechanical properties of breast implants will be evaluated by uniaxial tensile tests
Measured: After extraction of breast implants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start28 Feb 2022
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging of Breast ImplantsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- laetitia RUFFENACH, MD, Principal investigator, Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527132
- Sponsor's protocol ID
- 8528
- Acronym
- CRIMA
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Phenomena of Aging and Rupture of Breast Implants
- ClinicalTrials.gov ID
- NCT05527132
- Acronym / sponsor ID
- CRIMA / 8528
- Conditions
- Aging of Breast Implants
- Keywords
- Breast Prosthesis Implantation, Aging of breast implants, Rupture of breast implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The mechanical properties of breast implants will be evaluated by uniaxial tensile tests
Time frame: After extraction of breast implants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
laetitia RUFFENACH, MD principal investigator
Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging of Breast Implants, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact laetitia RUFFENACH, MD (33 3 68 76 51 67, laetitia.ruffenach@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mechanical properties of breast implants will be evaluated by uniaxial tensile tests (time frame: After extraction of breast implants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.