Идёт набор NCT07679594

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

— Наблюдательное Breast Augmentation Breast Reconstruction Breast Revision-Augmentation Breast Reconstruction With Silicone Implants

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Breast augmentation surgery, Breast reconstruction surgery.
Кому может быть актуально: Состояния в реестре: Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants. Базовые параметры: 18 лет — 65 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция, Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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.

Обзор

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.

Вмешательства

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

Первичные конечные точки

Frequency and rate of implant rupture [Срок оценки: 10 years]
Frequency and rate of capsular contracture Baker III-IV [Срок оценки: 10 years]

Вторичные конечные точки (3)

Rate of the secondary surgical procedures required for correction of complications [Срок оценки: 10 years]
Rate and frequency of local complications [Срок оценки: 10 years]
Patient satisfaction [Срок оценки: 10 years]

Критерии участия

Критерии включения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да