Breast ReconstructionPERLE10PMCFNCT06013514
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
An observational study of Breast Reconstruction and Breast Reconstruction Following Mastectomy, run by GCA (Eurosilicone) at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision
- What is being tested?
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2024to Sep 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female 18-65 requiring breast surgery for iether augmentation, reconstruction or revision, meeting inclusion and non inclusion criteria
Who may be able to join
- 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:-
- 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.
Who cannot join
- Subjects undergoing implant augmentation with a BMI > 30 and undergoing reconstruction with a BMI >32.
- 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 have ADMs of synthetic origin.
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Manchester
Manchester, M13 9WL
Nasir N Principal Investigator, (0)161 276 8686 ext. +44, pals@mft.nhs.uk
Nabila Nasir
About this study
Official title: A Prospective, Multi-center, Observational, Non Comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Nagor PERLE Range of Silicone Breast Implants When Used in Breast Implantation
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.
Read more
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
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation, Breast Reconstruction With Silicone Implants, Breast Reconstruction After Mastectomy
- Being tested
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Keywords
- prospective, observational, non-comparative, post-marketing study, PMCF, Perle, Nagor, GCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERLE Sterile Smooth Opaque gel filled mammary implantsDevice
Sterile smooth opaque gel filled mammary implants will be implanted in adult women having breast surgery for either augmentation, reconstruction or revision surgery. Different ranges of implants will be used to suit patient needs
| Study group | Role | What they receive |
|---|---|---|
| Smooth Silicone Breast Implant | Not described Receives: Device: PERLE Sterile Smooth Opaque gel filled mammary implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of capsular contracture (Baker grade III-IV)
Measured: 10 years post-surgery
Rate of implant rupture
Measured: 10 years post-surgery
Secondary outcomes (4)
Rate of the secondary surgical procedures required for correction of complications
Measured: 10 years post-surgery
Rate and frequency of local complications associated with the use of Nagor gel-filled mammary implants
- Capsular contracture of Baker Grade I-II
- Haematoma
- Rupture
- Seroma
- Severe and continuing pain
- Post-operative infection
- Explantation as a result of infection
- Implant displacement/extrusion
- Wrinkling/folds
- Breast Implant Associate Anaplastic Large Cell Lymphoma
- BII/Asia
- Delayed or abnormal wound healing occurring within the first 3 months of surgery
- Any other complications considered by the Investigator to be related to the device or surgical procedure
Measured: 10 years post-surgery
Patient satisfaction
BREAST- Q method
Measured: 10 years post-surgery
rate and frequency of any adverse events
Measured: 10 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Jun 2024
- Primary completionSep 2038 (estimated)
- Study completionSep 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCA (Eurosilicone)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013514
- Sponsor's protocol ID
- DM6 640 0101
- Acronym
- PERLE10PMCF
- Status last verified
- Jun 2026
- First submitted
- 22 Aug 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Observational, Non Comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Nagor PERLE Range of Silicone Breast Implants When Used in Breast Implantation
- ClinicalTrials.gov ID
- NCT06013514
- Acronym / sponsor ID
- PERLE10PMCF / DM6 640 0101
- Conditions
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation, Breast Reconstruction With Silicone Implants, Breast Reconstruction After Mastectomy
- Keywords
- prospective, observational, non-comparative, post-marketing study, PMCF, Perle, Nagor, GCA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GCA (Eurosilicone)Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Sep 2038 (estimated)
- Study completion
- Sep 2038 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smooth Silicone Breast Implant | – | Device: PERLE Sterile Smooth Opaque gel filled mammary implants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female 18-65 requiring breast surgery for iether augmentation, reconstruction or revision, meeting inclusion and non inclusion criteria
Key inclusion criteria (3 listed)
- 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:-
- 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.
Key exclusion criteria (13 listed)
- Subjects undergoing implant augmentation with a BMI > 30 and undergoing reconstruction with a BMI >32.
- 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 have ADMs of synthetic origin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PERLE Sterile Smooth Opaque gel filled mammary implantsSterile smooth opaque gel filled mammary implants will be implanted in adult women having breast surgery for either augmentation, reconstruction or revision surgery. Different ranges of implants will be used to suit patient needs | Device | Smooth Silicone Breast Implant |
Primary outcome
Rate of capsular contracture (Baker grade III-IV)
Time frame: 10 years post-surgery
Rate of implant rupture
Time frame: 10 years post-surgery
4 secondary outcomes
Rate of the secondary surgical procedures required for correction of complications
Time frame: 10 years post-surgery
Rate and frequency of local complications associated with the use of Nagor gel-filled mammary implants
Time frame: 10 years post-surgery
Patient satisfaction
Time frame: 10 years post-surgery
rate and frequency of any adverse events
Time frame: 10 years post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Reconstruction and Breast Reconstruction Following Mastectomy, run by GCA (Eurosilicone) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabila Nasir, Dr ((0)161 276 868, pals@mft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of capsular contracture (Baker grade III-IV) (time frame: 10 years post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.