Understanding the Phenomena of Aging and Rupture of Breas... | NCT05527132

Studies
Understanding the Phenomena of Aging and Rupture of Breast Implants

NCT05527132

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Nov 8, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Aging of Breast Implants

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2022Actual

Primary Completion Date

Jan 31, 2025Estimated

Completion Date

Jan 31, 2025Estimated

First Submitted Date

Aug 30, 2022

First Submission Date that Met QC Criteria

Sep 1, 2022

First Posted Date

Sep 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2023

Last Update Posted Date

Nov 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
laetitia RUFFENACH, MD	Contact	33 3 68 76 51 67		laetitia.ruffenach@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
laetitia RUFFENACH, MD	Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France