Breast Implant; ComplicationsIM02NCT04968457
Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants
An observational study of Breast Implant; Complications, run by Groupe SEBBIN.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Implant; Complications
- How many people
- 908 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Enrollment in the study was proposed to women over 18-year who were scheduled for a breast augmentation or breast reconstruction with SEBBIN silicone gel-filled breast implants.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 this study
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.
- Conditions
- Breast Implant; Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication
complication rate
Measured: At 10 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study startJan 2014
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 908 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe SEBBIN
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968457
- Sponsor's protocol ID
- PEC 15-10-001
- Acronym
- IM02
- Status last verified
- Mar 2024
- First submitted
- 6 Jul 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants
- ClinicalTrials.gov ID
- NCT04968457
- Acronym / sponsor ID
- IM02 / PEC 15-10-001
- Conditions
- Breast Implant; Complications
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 908 participants (actual)
- Lead sponsor
- Groupe SEBBINIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollment in the study was proposed to women over 18-year who were scheduled for a breast augmentation or breast reconstruction with SEBBIN silicone gel-filled breast implants.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complication
Time frame: At 10 years of follow-up
complication rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
Related trials for Breast Implant; Complications
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
Local Antibiotics for Breast Implants
Implant Complication, Implant Infection
RecruitingObservational study
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
Breast Implant Complication, Breast Implant Shell Defect
RecruitingObservational study
Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants
Systemic Symptoms, Breast Implant Illness
Not yet recruitingObservational study
Quality of Life of Patients Who Have Undergone Bilateral Mastectomy
Surgery Date, Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant; Complications, run by Groupe SEBBIN.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication (time frame: At 10 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.