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Post-market Prospective Clinical Study of Nagor Perle Mammary Implants

Sponsor: GCA (Eurosilicone)

NCT ID: NCT06013514

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
PERLE Sterile Smooth Opaque gel filled mammary implants (device)
How long the study runs
Study runs about 171 months (dates as stated)
About the drug or intervention
PERLE Sterile Smooth Opaque gel filled mammary implants — device: Sterile smooth opaque gel filled mammary implants will be implanted in adult women having breast surgery for either augmentation, reconstruction or revision surgery.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years to 65 Years
Who
Female
Number of participants
60
Started
2024-06-01
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for breast reconstruction
  • • Clinical study - 60 participants
  • • Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with breast reconstruction
  • • Female only

Where?

  • • Manchester - NHS Manchester

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Breast ReconstructionBreast Reconstruction Following MastectomyBreast RevisionBreast AugmentationBreast Reconstruction With Silicone ImplantsBreast Reconstruction After MastectomyBreast Reconstruction SurgeryBreast Implants

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: Female only

What the study is looking for

  • ✓Genetic female subjects aged ≥18 and ≤65
  • ✓Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:-

Who cannot take part

  • ✗Subjects undergoing implant augmentation with a BMI \> 30 and undergoing reconstruction with a BMI \>32.
  • ✗Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin...
  • ✗Subjects who have ADMs of synthetic origin.
  • ✗Subjects who, in the Investigator's clinical opinion, have existing local or that has spread carcinoma of the breast that...
  • ✗Subjects with known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are...
See the full criteria
Inclusion Criteria: 1. Genetic female subjects aged ≥18 and ≤65 2. 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 of animal origin (bovine, porcine)). ii) Primary breast augmentation (cosmetic surgery) with or without mastopexy iii) Breast revision surgery with or without mastopexy c) Subjects who have received a Nagor PERLE 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: 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 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. 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 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 breast feeders who do not stop breast feeding within 3 months of getting breast implants 13. Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant

Where Is This Study? (1 UK site)

NHS Manchester

Manchester M13 9WL, United Kingdom

Recruiting
Site contact (verified)
Nabila NasirPrincipal Investigator
Nasir N Principal Investigator(0)161 276 8686pals@mft.nhs.uk

How to Get in Touch

Nabila Nasir, Dr

Sponsor contact

CONTACT

(0)161 276 868 pals@mft.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-06