NCT05987475

Brief Summary

Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT

Trial Health

77
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
101mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress23%
Oct 2023Sep 2034

First Submitted

Initial submission to the registry

July 25, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 18, 2023

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2034

Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

10.9 years

First QC Date

July 25, 2023

Last Update Submit

November 28, 2023

Conditions

Breast Implant RuptureBreast Implant; Complications

Outcome Measures

Primary Outcomes (2)

  • Rate of capsular contracture

    To describe the rate of capsular contracture. Capsular contracture will be evaluated according to the Baker classification (from I to IV with grade III/IV considered as retractile capsular contractures).

    From implantation to end of study (10-year)

  • Post-surgery rupture

    To describe the rate of post-surgery rupture. Rupture will be evaluated based on cases of hardening or deflation, based on clinical signs and if deemed necessary by the investigator, by medical imaging (mammography, ultrasound, MRI).

    From implantation to end of study (10-year)

Secondary Outcomes (5)

  • Participant's QoL

    From implantation to end of study (10-year)

  • Breast implant survival rate.

    From implantation to end of study (10-year)

  • Frequency of occurrence of other adverse events and complications

    From implantation to end of study (10-year)

  • Participant's and investigator's satisfaction regarding the aesthetic result

    From implantation to end of study (10-year)

  • Reoperation rate

    From implantation to end of study (10-year)

Interventions

Breast reconstructionPROCEDURE

Breast reconstruction and breast augmentation based on the indications as listed out in the instructions for use of the medical device under investigation

Also known as: Breast augmentation

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Two groups of participants will be distinguished: * Group 1: Insertion of an implant in the event of a breast augmentation (for aesthetic reasons) * Group 2: Insertion of an implant in the event of a breast reconstruction (eg.. following breast cancer)

You may qualify if:

  • Female;
  • years old and above, and under 60 years old;
  • has approved and signed the informed consent form;
  • eligible to receive at least one EUROMI Biosciences implant during breast reconstruction following a mastectomy or during aesthetic breast surgery;
  • Willing to be followed up for a period of 10 years.

You may not qualify if:

  • Known hypersensitivity and / or allergy to silicone;
  • Not understanding or not accepting the risks of further surgeries during follow-up;
  • Body mass index \> 40 kg/m²;
  • Diabetes
  • HbA1c levels \> 7,5%;
  • History of repeated failure with the implantation of similar implants;
  • Tissue or fat insufficiency;
  • Progressive breast cancer large tumours (\>5 cm), late cancer stage and deep tumours;
  • Grossly positive axillary involvement / or chest wall involvement;
  • High risk of cancer recurrence;
  • Tissue damage in the implant area due to irradiation of the thoracic wall;
  • Pre-existing pathology in the implant area;
  • General infection or infection in the implant area;
  • Medical condition (poor physiological condition, psychological instability, severe smoking, obesity, coagulopathy, diabetes, severe cardiovascular or pulmonary disease, etc.) Which may, according to the judgement of the surgeon, entail excessive risk and/or post-surgical complications;
  • History or presence of an autoimmune disease;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, France

RECRUITING

MeSH Terms

Interventions

Mammaplasty

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsPlastic Surgery ProceduresSurgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 14, 2023

Study Start

October 18, 2023

Primary Completion (Estimated)

September 1, 2034

Study Completion (Estimated)

September 1, 2034

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

FR(1)