ComplicationNCT05642390
SEBBIN INTEGRITY Round Implants
An observational study of Complication and Prosthesis Durability, run by Groupe SEBBIN at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Complication, Prosthesis Durability
- What is being tested?
- Breast implant
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2022to 25 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be recruited from prospective adult patients operated for breast augmentation or reconstruction, unilaterally or bilaterally with SEBBIN silicone gel filled INTEGRITY mammary implants.
Who may be able to join
- 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.
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 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study About SEBBIN Silicone Gel-filled INTEGRITY Mammary Implants
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.
- Conditions
- Complication, Prosthesis Durability
- Being tested
- Breast implant
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast implantDevice
Patients operated for breast augmentation or reconstruction.
What is being measured
The primary outcome is the main question the study is designed to answer.
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 posted8 Dec 2022
- Study start11 Mar 2022
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Why it stopped: sponsor's strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationStudies 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
- 5 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
- NCT05642390
- Sponsor's protocol ID
- PEC 20-08-001
- Status last verified
- Oct 2024
- First submitted
- 30 Nov 2022
- Last updated
- 1 Nov 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study About SEBBIN Silicone Gel-filled INTEGRITY Mammary Implants
- ClinicalTrials.gov ID
- NCT05642390
- Acronym / sponsor ID
- PEC 20-08-001
- Conditions
- Complication, Prosthesis Durability
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: sponsor's strategic decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Groupe SEBBINIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 8 Dec 2022 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be recruited from prospective adult patients operated for breast augmentation or reconstruction, unilaterally or bilaterally with SEBBIN silicone gel filled INTEGRITY mammary implants.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast implantPatients operated for breast augmentation or reconstruction. | Device | – |
Primary outcome
Complication rate
Time frame: At 10 years of follow-up
Results and safety
The study was stopped early (reason given: sponsor's strategic decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication and Prosthesis Durability, run by Groupe SEBBIN at 1 site in France.
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 11 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: stopped early, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: sponsor's strategic decision). Results are not available in the source record.
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 rate (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 1 Nov 2024.