A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants

NCT07679594 | Recruiting

• 1 other identifier: CLA-0007
• Study Type: observational
• Target: 650
• Locations: 2 countries
• Sites: 2

Brief Summary

The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical implantation in female population between 18 and 65 years old undergoing primary or revision of breast augmentation or breast reconstruction.

Conditions

Breast Augmentation; Breast Reconstruction; Breast Revision-Augmentation; Breast Reconstruction With Silicone Implants; Breast Reconstruction, Revision Breast Reconstruction; Breast Augmentation and Breast Reconstruction

Keywords

Luna XT; Anatomical breast implant; Mammary implant

Outcome Measures

Primary Outcomes (2)

• Frequency and rate of implant rupture

  10 years

• Frequency and rate of capsular contracture Baker III-IV

  10 years

Secondary Outcomes (3)

• Rate of the secondary surgical procedures required for correction of complications

  10 years

• Rate and frequency of local complications

  10 years

• Patient satisfaction

  10 years

Study Arms (2)

Aesthetic indications

Primary or revision breast augmentation with or without mastopexy.

Procedure: Breast augmentation surgery

Medical indications

Primary or revision of breast reconstruction. Immediate or delayed reconstruction. With or without associated chemotherapy and/or radiotherapy.

Procedure: Breast reconstruction surgery

Interventions

Breast augmentation surgery PROCEDURE

The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.

Also known as: Cosmetic breast implant surgery, Aesthetic breast implant surgery

Aesthetic indications

Breast reconstruction surgery PROCEDURE

The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.

Also known as: Immediate breast reconstruction, Delayed breast reconstruction

Medical indications

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Genetic female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from centers participating to the study.

You may qualify if:

• The target population includes subjects undergoing augmentation or reconstructive breast implant surgery in which the Eurosilicone Luna mammary implant is recommended.
• Genetic female subjects aged between 18 and 65 years old.
• Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:
• i. Primary breast reconstruction following mastectomy (both for one-stage or two-stage surgeries, including patients with previous radiotherapy and who have ADMs (synthetic or natural).
• ii. Primary breast augmentation (cosmetic surgery) with or without mastopexy iii. Breast revision surgery with or without mastopexy c) Subjects who have received a Eurosilicone Luna implant. d) Subjects who have provided informed consent and can adhere to the requirements of follow-up appointments as per the study protocol.

You may not qualify if:

• Subjects with a BMI \>35.
• Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere with wound healing and blood clotting, a weakened immune system, reduced blood supply to the breast tissue or any other condition for which breast implants are contraindicated.
• Subjects who have participated in a clinical study which involve chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer-related clinical studies.
• Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.
• Subjects who, in the Investigator's clinical opinion, have existing local or metastatic carcinoma of the breast that is unlikely to be fully excised at the time of insertion of the breast implant.
• Subjects with known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery.
• Subjects with an active infection who are unsuitable for surgery unless, in the opinion of the investigator, they are treated and cleared by the investigator.
• Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery.
• Subjects with a known history of compromised wound healing.
• Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
• Women who are pregnant and/or current breast feeders who do not stop breast feeding within 3 months of getting breast implants.
• Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant.

Sponsors & Collaborators

• GCA (Eurosilicone): lead

Study Sites (2)

Dr Guillaume Lasserre

Villefranche-sur-Saône, France

RECRUITING

DScultp Clinic

Barcelona, Spain

RECRUITING

Central Study Contacts

GCA Clinical affairs department

CONTACT

+33 783326098; luna10PMCF@gcaesthetics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 31, 2038
• Study Completion (Estimated): December 31, 2038
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); ES (1)