Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02206282
NCT02206282CompletedNot Applicable

Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

Silimed Industria de Implantes Ltda0 sites390 target enrollmentStarted: August 2006Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
390
Primary Endpoint
Magnetic Resonance Image
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

A prospective clinical research is to assess the prevalence of implant rupture and presence of extracapsular gel in an un-referred population of women who have been implanted with the Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subject implanted with the original Silimed gel-filled implant.

Exclusion Criteria

  • •MR imaging is not possible because of the following:
  • •Metal implant
  • •Battery activated stimulator
  • •Pregnancy
  • •Body weight >300 pounds
  • •History of metal fragments in the eye
  • •Any other contraindication to MR exam.

Outcomes

Primary Outcomes

Magnetic Resonance Image

Time Frame: 1 year

390 Magnetic Resonance Images.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

Completed
Not Applicable
Early and Late Implant FailureDental Implant FailedPeri-Implantitis
NCT04270396Universitat Internacional de Catalunya190
Recruiting
Not Applicable
Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbidity, Mortality, Treatment and Outcome AnalysisPeriprosthetic Fracture of the Upper or Lower LimbPeri-implant Fracture of the Upper or Lower LimbPeriprosthetic FracturesPeri-implant Fracture
NCT04663893Hospital Clínico Universitario de Valladolid2,500
Not yet recruiting
Not Applicable
Prevalence and Risk Indicators of Peri-implant Diseases in ChinaPeri-Implantitis
NCT06208254Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University500
Completed
Not Applicable
Evaluation of the Prevalence Rate and Related Risk Factors of Ridge PreservationDental Implants
NCT06742151Chimei Medical Center133
Completed
Phase 4
A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of SPI ImplantImplant Clinical SurvivalDental Implant Bone Loss
NCT02367261Alpha - Bio Tec Ltd.88
Prevalence of Asymptomatic Rupture in... | Clinical Trial