A post-market prospective clinical study of Nagor PERLE™ mammary implants
- Conditions
- Breast surgery: augmentation and reconstruction including revision for womenSurgery
- Registration Number
- ISRCTN96851026
- Lead Sponsor
- agor Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 700
1. Genetic female subjects aged =18 and =65 years
2. Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:
2.1. Primary breast reconstruction following mastectomy (both for one-stage or two-stage surgeries, including patients with previous radiotherapy and who have ADMs of animal origin (bovine, porcine)).
2.2. Primary breast augmentation (cosmetic surgery) with or without mastopexy
2.3. Breast revision surgery with or without mastopexy
3. Subjects who have received a Nagor PERLE implant.
4. Subjects who have provided informed consent and can adhere to the requirements of follow-up appointments as per the study protocol.
1. Subjects undergoing implant augmentation with a BMI > 30 and undergoing reconstruction with a BMI >32
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 involves 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 have ADMs of synthetic origin
6. 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
7. Subjects with a known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery
8. 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
9. Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery
10. Subjects with a known history of compromised wound healing
11. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study
12. Women who are pregnant and/or current breastfeeders who do not stop breastfeeding within 3 months of getting breast implants
13. Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency and rate of capsular contracture of Baker grade III-IV and rupture at 1, 3, 5, 8 and 10 years using adverse event forms
- Secondary Outcome Measures
Name Time Method 1. Rate of the secondary surgical procedures required for correction of complications over a 10-year period following surgical implantation at any time during unscheduled follow-up using additional intervention form<br>2. Rate and frequency of local complications at 1, 3, 5, 8 and 10 years using adverse event reports<br>3. Perfomance associated with patient satisfaction at 1, 3, 5, 8 and 10 years using the Breast-Q method <br>4. Adverse effects observed at 1, 3, 5, 8 and 10 years using adverse event reports<br>5. Rate and frequency of any adverse events at 1, 3, 5, 8 and 10 years using adverse event reports<br>