Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
5 participants
OBSERVATIONAL
2022-03-11
2024-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Breast implant
Patients operated for breast augmentation or reconstruction.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Groupe SEBBIN
INDUSTRY
Responsible Party
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Locations
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SEBBIN
Saint-Ouen-l'Aumône, , France
Countries
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Other Identifiers
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PEC 20-08-001
Identifier Type: -
Identifier Source: org_study_id
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