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RecruitingNCT06147661AMEPUpdated Nov 27, 2023

Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue

An observational study in Breast Implants, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
119
Ages
18 Years and older
Sex
Female
01

Study summary

The use of autograft of adipose tissue for aesthetic breast augmentation is increasing year after year. According to the latest meta-analysis of 2016, autograft of adipose tissue in augmentation mastoplasty seems to be a promising method with a satisfactory resorption volume and patient and surgeon satisfaction. However, this technique allows for small to moderate breast augmentation and is therefore not suitable for patients wanting a significant increase.

Breast prostheses allow a significant increase. Numerous studies have shown an improvement in patient satisfaction and quality of life assessed using the BREAST-Q questionnaire.

On the other hand, very few studies have objectively evaluated the satisfaction of patients who have benefited from an autograft of adipose tissue as part of aesthetic breast augmentation. No study has yet compared the satisfaction of patients who have benefited from breast implants or lipofilling.

The aim of this study is to compare the satisfaction of patients who have benefited from breast augmentation by prosthesis or by lipofilling using a remote satisfaction interview.

02

Conditions studied

  • Breast Implants

Keywords

  • Breast Prosthesis
  • Breast Implants
03

In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 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
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult woman (age ≥ 18 years) having benefited from primary aesthetic breast augmentation at Strasbourg University Hospital between June 27, 2017 and June 27, 2022

Inclusion criteria

  • Adult woman (age ≥ 18 years)
  • having benefited from primary aesthetic breast augmentation at Strasbourg University Hospital between June 27, 2017 and June 27, 2022
  • not opposing the reuse of its data for scientific research purposes.

Exclusion criteria

Exclusion Criteria:

  • Woman who expressed her opposition to the reuse of her data for scientific research purposes
  • Woman with a breast malformation: tuberous breasts or breast asymmetry of more than one cup
  • Woman with comprehension difficulties
  • Woman under guardianship or curatorship
05

Study design

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

What researchers measure

Primary outcomes

  1. Patient woman satisfaction

    This satisfaction will be assessed using a remote satisfaction interview

    Time frame: 1 to 4 years after breast implants

07

Study locations

1 of 1 sites recruiting
  • Service de Chirurgie Plastique, Reconstructrice et Esthétique - CHU de Strasbourg - France
    Strasbourg, 67091, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06147661
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Nov 27, 2023
Start date
Jun 1, 2023
Primary completion
Jan 2024 (estimated)
Completion
Jan 22, 2024 (estimated)
Last update
Nov 27, 2023

Study contacts

Frédéric BODIN, MD, PhD
Contact
frederic.bodin@chru-strasbourg.fr
33 3 68 76 51 67

Oversight

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

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