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OpenTrials
Active, Not Recruiting

NCT Number: NCT04968457

Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Complication

    Time frame: At 10 years of follow-up

    complication rate

Sponsors and collaborators

Lead sponsor

Groupe SEBBIN

Industry

Registry information

Acronym: IM02

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2021
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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