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

1 juli 2026 uppdaterad av: GCA (Eurosilicone)

A Prospective, Multi-centre, Observational, Non-comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Eurosilicone LunaXT Range of Silicone Breast Implants When Used in Breast Implantation.

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

650

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients from centers participating to the study.

Beskrivning

Inclusion Criteria:

  • The target population includes subjects undergoing augmentation or reconstructive breast implant surgery in which the Eurosilicone Luna mammary implant is recommended.

Inclusion criteria are:

  1. Genetic female subjects aged between 18 and 65 years old.
  2. 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.

Exclusion criteria are:

  1. Subjects with a BMI >35.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Subjects with known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery.
  7. 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.
  8. Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery.
  9. Subjects with a known history of compromised wound healing.
  10. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
  11. Women who are pregnant and/or current breast feeders who do not stop breast feeding within 3 months of getting breast implants.
  12. Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Aesthetic indications
Primary or revision breast augmentation with or without mastopexy.
Procedur: Breast augmentation surgery
The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.
Andra namn:
  • Cosmetic breast implant surgery
  • Aesthetic breast implant surgery
Medical indications
Primary or revision of breast reconstruction. Immediate or delayed reconstruction. With or without associated chemotherapy and/or radiotherapy.
Procedur: Breast reconstruction surgery
The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.
Andra namn:
  • Omedelbar bröstrekonstruktion
  • Delayed breast reconstruction

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Frequency and rate of implant rupture
Tidsram: 10 years
10 years
Frequency and rate of capsular contracture Baker III-IV
Tidsram: 10 years
10 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of the secondary surgical procedures required for correction of complications
Tidsram: 10 years
10 years
Patient satisfaction
Tidsram: 10 years
This will be determined using a questionnaire assessing the qualify of life.
10 years
Rate and frequency of local complications
Tidsram: 10 years

These complications may be related to the device itself or to the surgical procedure:

  • Capsular contracture of Baker Grade I-II
  • Haematoma
  • Rupture
  • Seroma
  • Severe and continuing pain
  • Post-operative infection
  • Explantation as a result of infection
  • Implant displacement/extrusion
  • Implant misplacement/malrotation
  • Wrinkling/folds
  • Breast Implant Associate Anaplastic Large Cell Lymphoma
  • Breast Implant Ilness (BII)/ Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants (Asia)
  • Delayed or abnormal wound healing occurring within the first 3 months of surgery
  • Any other complications considered by the Investigator to be related to the device or surgical procedure
10 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GCA (Eurosilicone)

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 mars 2026

Primärt slutförande (Beräknad)

31 december 2038

Avslutad studie (Beräknad)

31 december 2038

Studieregistreringsdatum

Först inskickad

25 juni 2026

Först inskickad som uppfyllde QC-kriterierna

25 juni 2026

Första postat (Faktisk)

1 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • CLA-0007

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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