NCT02206282

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

4.3 years

First QC Date

July 28, 2014

Last Update Submit

July 30, 2014

Conditions

Breast Implant Rupture

Outcome Measures

Primary Outcomes (1)

  • Magnetic Resonance Image

    390 Magnetic Resonance Images.

    1 year

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

390 women (780 implants) from Rio de Janeiro and other Brazilian cities will be randomly selected to undergo MRI detection of asymptomatic rupture using a stratified sampling design, stratifying on implant age (time since implantation). Sixty-five (65) women will be selected from each of six implant age groups between 6-18 years.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Wanda Elizabeth Massiere Correa, MD

    Insituto Ivo Pitanguy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

August 1, 2014

Study Start

August 1, 2006

Primary Completion

November 1, 2010

Study Completion

February 1, 2011

Last Updated

August 1, 2014

Record last verified: 2014-07