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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04968457
Other study ID # PEC 15-10-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2014
Est. completion date January 2027

Study information

Verified date March 2024
Source Groupe SEBBIN
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 908
Est. completion date January 2027
Est. primary completion date January 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Groupe SEBBIN

Outcome

Type Measure Description Time frame Safety issue
Primary Complication complication rate At 10 years of follow-up
See also
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