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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (1 UK site)
NHS Manchester
Manchester M13 9WL, United Kingdom
How to Get in Touch
Nabila Nasir, Dr
Sponsor contactCONTACT
