NCT05062733

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
108mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Nov 2021Mar 2035

First Submitted

Initial submission to the registry

September 21, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 20, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2035

Expected
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

3.3 years

First QC Date

September 21, 2021

Last Update Submit

October 30, 2024

Conditions

ComplicationProsthesis Durability

Outcome Measures

Primary Outcomes (1)

  • Complication rate

    At 10 years of follow-up

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istituto Estetico Italiano

Roma, 00193, Italy

RECRUITING

Medical Clinic "Essential Aesthetics"

The Hague, 2582, Netherlands

RECRUITING

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2021

First Posted

September 30, 2021

Study Start

November 20, 2021

Primary Completion

March 1, 2025

Study Completion (Estimated)

March 1, 2035

Last Updated

October 31, 2024

Record last verified: 2024-10

Locations

IT(1)NL(1)