TerminatedNot Applicable

SEBBIN INTEGRITY Round Implants

Stopped: sponsor's strategic decision

France5 participantsStarted 2022-03-11

Plain-language summary

This study is part of the clinical evaluation of SEBBIN silicone gel-filled INTEGRITY implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complication rate

Timeframe: At 10 years of follow-up

Trial details

NCT IDNCT05642390

SponsorGroupe SEBBIN

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-25

View on ClinicalTrials.gov More Complication trials