Trial Information
Current as of January 22, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • The patient is at least 18-year-old.
- • The patient is a woman.
- • The patient was prescribed with a surgery for a breast augmentation or reconstruction, unilaterally or bilaterally with silicone gel-filled SEBBIN INTEGRITY mammary implants.
- • The patient has been informed of the study, has read the patient information letter and provided consent in writing.
- 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.
- • History of implant-associated anaplastic large cell lymphoma (BIA-ALCL).
- • Symptomatic autoimmune 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.
About Groupe Sebbin
Groupe Sebbin is a prominent French company specializing in the development and manufacturing of medical devices and innovative solutions in the field of aesthetic and reconstructive surgery. With a strong commitment to quality and safety, Groupe Sebbin leverages advanced technologies and rigorous clinical research to deliver high-performance products, including silicone implants and surgical instruments. The company is dedicated to enhancing patient outcomes and satisfaction through continuous innovation, comprehensive training for healthcare professionals, and adherence to international regulatory standards. By actively engaging in clinical trials, Groupe Sebbin aims to contribute to the evolving landscape of medical aesthetics and improve the standards of care within the industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Saint Ouen L'aumône, , France
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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