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RecruitingNCT05062733Updated Oct 31, 2024

SEBBIN Round, Anatomical and Biconvex Gluteal Implants

An observational study in Complication and Prosthesis Durability, sponsored by Groupe SEBBIN. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by Groupe SEBBIN · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Nov 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Complication
  • Prosthesis Durability

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03

In context

Prosthesis Failure

113 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 60 is below the median of 150 across 45 observational studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

Lead sponsor

Groupe SEBBIN is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Complication rate

    Time frame: At 10 years of follow-up

07

Study locations

2 of 2 sites recruiting
  • Istituto Estetico Italiano
    Roma, 00193, Italy
    • Valerio Badiali, MD · Contact · info@valeriobadiali.com · +39 393 968 3014
    • Valerio Badiali, MD · Principal investigator
    Recruiting
  • Medical Clinic "Essential Aesthetics"
    The Hague, 2582, Netherlands
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2021 (actual). Primary completion is estimated for Mar 2025, 40 months after the start.

Of 25 observational studies under Prosthesis Failure, half reached primary completion within 181 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 184. This study's planned 40 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2021
First posted
Sep 30, 2021
StartActual
Nov 20, 2021
Primary completionEst.
Mar 2025
CompletionEst.
Mar 2035
Last update
Oct 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05062733
Lead sponsor
Groupe SEBBIN
Responsible party
Sponsor
First posted
Sep 30, 2021
Start date
Nov 20, 2021
Primary completion
Mar 2025 (estimated)
Completion
Mar 2035 (estimated)
Last update
Oct 31, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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