Safety Follow-up Study in Subjects With Silicone Gel-filled Breast Implants as Compared Both to Saline-filled Breast Implants and to National Norms

Study acronym: BIFS
StatusActive, Not Recruiting
PhaseNot specified
SponsorAllergan
Started

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Record History

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  1. 3 versions Re-verified since Nov 10, 2023, no change to tracked fieldsv33-v35
  2. Primary and study completion dates: Jul 21, 2023 to Dec 31, 2029
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v32
  3. Re-verified, no change to tracked fieldsv31
  4. Trial status: Active, Not Recruiting to Recruitingv30 Show 5 more changesShow less
    • Primary and study completion dates moved earlier to Jul 21, 2023
    • Study sites: 638 to 1
    • Interventions: 410 Arm (Device), BIFs (Device), NBIR Placeholder (Other) to 410 Arm (Device), BIFs - Breast Implant Follow-Up Study (Device), NBIR - US National Breast Implant Registry (Other)
    • Eligibility criteria expanded, about 269 words
    • Study arms: 3 to 0
  5. Study sites: 636 to 638
    • Primary completion date: Apr 18, 2030 to Jul 31, 2030
    • Study completion date: Jun 1, 2030 to Dec 31, 2030
    v29
Show 27 earlier versionsHide 27 earlier versions
  1. Primary completion date: Oct 31, 2028 to Apr 18, 2030v28 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 57000 to confirmed 56460
    • Study sites: 1777 to 636
    • Study completion date: Oct 31, 2028 to Jun 1, 2030
  2. Site details revised at 32 of 1777 sitesv27
  3. Re-verified, no change to tracked fieldsv26
  4. Site details revised at 2 of 1777 sitesv25
  5. Study sites: 1765 to 1777v24
  6. Primary and study completion dates: Oct 2026 to Oct 31, 2028
    • Study sites: 1769 to 1765
    • Start date: Nov 2006 to Nov 1, 2006
    • Interventions: 410 Arm (Device), BIFs (Device), NBIR Placeholder (Other)
    v23
  7. Study sites: 1722 to 1769v22
  8. Study sites: 2 to 1722v21
  9. Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Mar 2020 to Oct 2026
    • Study sites revised (2)
    • Study title expanded, about 11 words
    v20
  10. Lead sponsor: Allergan Medical to Allerganv19
  11. 3 versions Re-verified since Dec 3, 2013, no change to tracked fieldsv16-v18
  12. Primary completion date: Mar 2020v15
  13. Study sites: 1 to 2v14
  14. 4 versions Re-verified since Dec 20, 2010, no change to tracked fieldsv10-v13
  15. Enrollment target: estimated 55000 to confirmed 57000
    • Study completion date: Nov 2016 to Mar 2020
    v9
  16. Trial status: Recruiting to Active, Not Recruiting
    • Study site revised
    v8
  17. 2 versions Re-verified since Jun 18, 2009, no change to tracked fieldsv6-v7
  18. Enrollment target: 60000 to 55000
    • Eligibility criteria shortened, about 175 words
    v5
  19. Re-verified, no change to tracked fieldsv4
  20. Study completion date: Nov 2016
    • Start date: Nov 2006
    v3
  21. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AbbVie
350 trials monitored
See 26 trials at risk
Ten year safety study examining rates of rare adverse events, child bearing issues, effects of mammography, MRI compliance and results, and long-term benefit of silicone-filled breast implants.
Trial Details
NCT Number NCT00443274
Lead Sponsor Allergan
Conditions
(from sponsor)		 Breast Implant
Enrollment 56,460 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov