Actively Recruiting
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Led by GCA (Eurosilicone) · Updated on 2025-07-11
60
Participants Needed
1
Research Sites
743 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to maintain a record of safety and performance with all medical implants. This study is designed to collect data on a new generation of smooth mammary implants to assess the long term performance and safety data on this type of gel-filled mammary breast implant. The two main complications of breast implants are capsular contracture and rupture; these complications can take years to develop. The study is designed to evaluate the occurrence of these two primary complication as well as other secondary complications over a period of 10 years. Patient follow up will be carried out pre-operatively and post operatively at 12 months and then 3, 5, 8 and 10 years thereafter. The study will be carried out over 10 years to adequately assess complications which may only occur over the lifetime of the device such as systemic complications
CONDITIONS
Official Title
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Genetic female aged 18 to 65 years
- Underwent single or bilateral breast implantation with the study device for primary reconstruction after mastectomy, primary breast augmentation, or breast revision surgery
- Subjects may include those with previous radiotherapy and those with animal-derived acellular dermal matrices (ADM)
- Received a Nagor PERLE implant
- Provided informed consent and can attend follow-up appointments as required by the study protocol
You will not qualify if you...
- Implant augmentation candidates with BMI over 30 or reconstruction candidates with BMI over 32
- Autoimmune disease, fibrocystic lung disease, conditions affecting wound healing or blood clotting, weakened immune system, or reduced blood supply to breast tissue
- Participation in a clinical drug or chemical study within 3 months prior to surgery, except breast cancer-related studies
- Insufficient tissue coverage due to radiation damage, tight skin grafts, or major muscle resection
- Use of synthetic origin acellular dermal matrices (ADM)
- Existing local or metastatic breast cancer unlikely to be fully excised at implant insertion
- Known silicone sensitivity deemed unsuitable for surgery
- Active infection unsuitable for surgery unless treated and cleared
- History of abscesses deemed unsuitable for surgery
- Known compromised wound healing
- Any condition compromising participation or follow-up
- Pregnant or breastfeeding women who do not stop breastfeeding within 3 months after implant
- Local recurrence or metastatic carcinoma at time of implant insertion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NHS Manchester
Manchester, United Kingdom, United Kingdom, M13 9WL
Actively Recruiting
Research Team
C
Clinical Affairs Manager
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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