ComplicationNCT05062733
SEBBIN Round, Anatomical and Biconvex Gluteal Implants
An observational study of Complication and Prosthesis Durability, run by Groupe SEBBIN at 2 sites in 2 countries.
Trial summary
This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal 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
- Conditions the study is for
- Complication, Prosthesis Durability
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Nov 2021to Mar 2035
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The intended target population for the gluteal Implants is women or men, who desire an increase in volume of the gluteal region for aesthetic or reconstruction reason.
Who may be able to join
- The patient is a man or a woman ≥ 18 years old at the time of inclusion.
- The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision
- The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing.
Who cannot join
- Patient implanted with silicone implants somewhere else in the body.
- Patient candidate for implantation with custom-designed implants.
- Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
Istituto Estetico Italiano
Roma, 00193
Valerio Badiali, MD, +39 393 968 3014, info@valeriobadiali.com
Valerio Badiali, MD
Netherlands1 site, 1 recruiting
- Recruiting
Medical Clinic "Essential Aesthetics"
The Hague, 2582
Philippe Levan, MD, 925.855.1773, info@essentialaesthetics.net
Philippe Levan, MD
About this study
Official title: Prospective Observational Study About SEBBIN Gluteal Implants
This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal 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
- Medical subject headings
- Prosthesis Failure
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 posted30 Sep 2021
- Study start20 Nov 2021
- Primary completionMar 2025 (estimated)
- Study completionMar 2035 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe SEBBIN
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062733
- Sponsor's protocol ID
- PEC 20-07-001
- Status last verified
- Oct 2024
- First submitted
- 21 Sep 2021
- Last updated
- 31 Oct 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 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study About SEBBIN Gluteal Implants
- ClinicalTrials.gov ID
- NCT05062733
- Acronym / sponsor ID
- PEC 20-07-001
- Conditions
- Complication, Prosthesis Durability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Groupe SEBBINIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2035 (estimated)
- First posted
- 30 Sep 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.
This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal 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
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intended target population for the gluteal Implants is women or men, who desire an increase in volume of the gluteal region for aesthetic or reconstruction reason.
Key inclusion criteria (3 listed)
- The patient is a man or a woman ≥ 18 years old at the time of inclusion.
- The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision
- The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing.
Key exclusion criteria (3 listed)
- Patient implanted with silicone implants somewhere else in the body.
- Patient candidate for implantation with custom-designed implants.
- Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.
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 rate
Time frame: At 10 years of follow-up
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 31 Oct 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.
2 sites in 2 countries: 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 2 sites in 2 countries.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Netherlands. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 31 Oct 2024.