A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
1. juli 2026 oppdatert 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
650
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: GCA Clinical affairs department
- Telefonnummer: +33 783326098
- E-post: luna10PMCF@gcaesthetics.com
Studiesteder
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Villefranche-sur-Saône, Frankrike
- Rekruttering
- Dr Guillaume Lasserre
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Ta kontakt med:
- Dr Guillaume Lasserre
- E-post: dr.lasserre.guillaume@orange.fr
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Hovedetterforsker:
- Guillaume Lasserre
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Barcelona, Spania
- Rekruttering
- DScultp Clinic
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Ta kontakt med:
- Dr David Sanz
- E-post: administracion@plasticabarcelona.com
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Hovedetterforsker:
- David Sanz
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients from centers participating to the study.
Beskrivelse
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:
- 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.
Exclusion criteria are:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Aesthetic indications
Primary or revision breast augmentation with or without mastopexy.
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The procedure is carried out at the surgeon's discretion.
This includes the incision location, the implant placement, the intraoperative applications.
Andre navn:
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Medical indications
Primary or revision of breast reconstruction.
Immediate or delayed reconstruction.
With or without associated chemotherapy and/or radiotherapy.
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The procedure is carried out at the surgeon's discretion.
This includes the incision location, the implant placement, the intraoperative applications.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Frequency and rate of implant rupture
Tidsramme: 10 years
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10 years
|
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Frequency and rate of capsular contracture Baker III-IV
Tidsramme: 10 years
|
10 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of the secondary surgical procedures required for correction of complications
Tidsramme: 10 years
|
10 years
|
|
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Patient satisfaction
Tidsramme: 10 years
|
This will be determined using a questionnaire assessing the qualify of life.
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10 years
|
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Rate and frequency of local complications
Tidsramme: 10 years
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These complications may be related to the device itself or to the surgical procedure:
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10 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. mars 2026
Primær fullføring (Antatt)
31. desember 2038
Studiet fullført (Antatt)
31. desember 2038
Datoer for studieregistrering
Først innsendt
25. juni 2026
Først innsendt som oppfylte QC-kriteriene
25. juni 2026
Først lagt ut (Faktiske)
1. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CLA-0007
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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