A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
1. juli 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
650
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: GCA Clinical affairs department
- Telefonnummer: +33 783326098
- E-mail: luna10PMCF@gcaesthetics.com
Studiesteder
-
-
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Villefranche-sur-Saône, Frankrig
- Rekruttering
- Dr Guillaume Lasserre
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Kontakt:
- Dr Guillaume Lasserre
- E-mail: dr.lasserre.guillaume@orange.fr
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Ledende efterforsker:
- Guillaume Lasserre
-
-
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-
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Barcelona, Spanien
- Rekruttering
- DScultp Clinic
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Kontakt:
- Dr David Sanz
- E-mail: administracion@plasticabarcelona.com
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Ledende efterforsker:
- David Sanz
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Aesthetic indications
Primary or revision breast augmentation with or without mastopexy.
|
The procedure is carried out at the surgeon's discretion.
This includes the incision location, the implant placement, the intraoperative applications.
Andre navne:
|
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Medical indications
Primary or revision of breast reconstruction.
Immediate or delayed reconstruction.
With or without associated chemotherapy and/or radiotherapy.
|
The procedure is carried out at the surgeon's discretion.
This includes the incision location, the implant placement, the intraoperative applications.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Frequency and rate of implant rupture
Tidsramme: 10 years
|
10 years
|
|
Frequency and rate of capsular contracture Baker III-IV
Tidsramme: 10 years
|
10 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
10 years
|
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Rate and frequency of local complications
Tidsramme: 10 years
|
These complications may be related to the device itself or to the surgical procedure:
|
10 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. marts 2026
Primær færdiggørelse (Anslået)
31. december 2038
Studieafslutning (Anslået)
31. december 2038
Datoer for studieregistrering
Først indsendt
25. juni 2026
Først indsendt, der opfyldte QC-kriterier
25. juni 2026
Først opslået (Faktiske)
1. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CLA-0007
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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