NCT04968457

Brief Summary

The aim of the study is to allow Groupe SEBBIN to communicate to competent authorities and to the scientific community data relative to the safety and effectiveness of SEBBIN silicone gel-filled breast implants.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
908

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2014

Longer than P75 for all trials

Status
active not recruiting

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 Progress95%
Jan 2014Jan 2027

Study Start

First participant enrolled

January 1, 2014

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

13 years

First QC Date

July 6, 2021

Last Update Submit

March 5, 2024

Conditions

Breast Implant; Complications

Outcome Measures

Primary Outcomes (1)

  • Complication

    complication rate

    At 10 years of follow-up

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Enrollment in the study was proposed to women over 18-year who were scheduled for a breast augmentation or breast reconstruction with SEBBIN silicone gel-filled breast implants.

You may qualify if:

  • The patient is at least 18-year-old.
  • The patient is genetically a woman.
  • The patient is candidate to a breast augmentation or breast reconstruction with silicone gel-filled breast implants.
  • The patient gets all information regarding the study and signs the informed consent relative to the use of her personal data.

You may not qualify if:

  • The patient is pregnant or breastfeeding.
  • The patient has silicone implants somewhere else than in the breast.
  • The patient was diagnosed with one of the following pathologies:
  • Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
  • Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
  • Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
  • The patient has a pathology that could delay healing (does not apply to the reconstruction group).
  • The patient has cancer (does not apply to the reconstruction group).
  • The patient has anatomical or physiological conditions that could lead to postoperative complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 20, 2021

Study Start

January 1, 2014

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

March 6, 2024

Record last verified: 2024-03