A post-market prospective clinical study of Nagor PERLE™ mammary implants
| ISRCTN | ISRCTN96851026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96851026 |
| IRAS number | 331001 |
| ClinicalTrials.gov number | NCT06013514 |
| Secondary identifying numbers | Protocol DM6 640 103, IRAS 331001, CPMS 58062 |
- Submission date
- 23/08/2023
- Registration date
- 08/09/2023
- Last edited
- 02/11/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
PERLE™ is a smooth round implant intended for breast augmentation or reconstruction and is approved for commercialisation. To assess the safety and performance of this implant the manufacturer Nagor is studying the rate of adverse events and satisfaction over a 10-year period.
Who can participate?
Women aged 18 to 65 years who underwent single or bilateral breast implantation
What does the study involve?
Follow-up visits will happen at specific points: 1, 3, 5, 8 and 10 years. Patients will fill in a quality of life survey. The research team will investigate any adverse events that have happened since the last follow-up. Surgeons will be asked about their satisfaction with the clinical outcomes.
What are the possible benefits and risks of participating?
No benefits are expected except for a better understanding of the breast implants' long-term safety. Expected risks of participating are minimal and only apply to data leaking as no additional interventions are expected except for standard practice.
Where is the study run from?
Manchester Private Hospital (UK)
When is the study starting and how long is it expected to run for?
August 2022 to December 2035
Who is funding the study?
Nagor Ltd (UK)
Who is the main contact?
perle10pmcf@gcaesthetics.com
Contact information
Principal Investigator
Manchester Private Hospital
New Court
Regents Place
Windsor Street
Salford
Manchester
M5 4HB
United Kingdom
| Phone | +44 (0)161 795 4567 |
|---|---|
| Nabila.nasir@mft.nhs.uk |
Public
Nagor Ltd, 129 Deerdykes View
Westfield Industrial Estate
Cumbernauld
Glasgow
G68 9HN
United Kingdom
| Phone | +44 (0)1236780780 |
|---|---|
| chrystellebarrier@gcaesthetics.com |
Study information
| Study design | Prospective multi-center observational non-comparative unblind postmarketing surveillance study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life, Safety, Efficacy |
| Participant information sheet | Not available in web format, please contact details to request a participant information sheet |
| Scientific title | A prospective, multi-center, observational, non-comparative, postmarketing surveillance study to obtain clinical outcome data on the Nagor PERLE™ range of silicone breast implants when used in breast augmentation or reconstruction for women from 18 to 65 years |
| Study acronym | PERLE10PMCF |
| Study hypothesis | Observational study: assessment of safety and performance (rate of adverse event and satisfaction) |
| Ethics approval(s) |
Approved 09/10/2023, West of Scotland REC 4 (Research Ethics Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 314 0213; WoSREC4@ggc.scot.nhs.uk), ref: 23/WS/0130 |
| Condition | Breast surgery: augmentation and reconstruction including revision for women |
| Intervention | Patients will have follow-up visits at 1, 3, 5, 8 and 10 years after breast surgery where they will assess their well-being by filling out a Breast-Q survey, and any adverse events are recorded with adverse event report forms. Surgeons will be asked for their feedback on the product (usage, clinical outcomes, satisfaction). |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Perle round, smooth breast implant |
| Primary outcome measure | 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 | 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 2. Rate and frequency of local complications at 1, 3, 5, 8 and 10 years using adverse event reports 3. Perfomance associated with patient satisfaction at 1, 3, 5, 8 and 10 years using the Breast-Q method 4. Adverse effects observed at 1, 3, 5, 8 and 10 years using adverse event reports 5. Rate and frequency of any adverse events at 1, 3, 5, 8 and 10 years using adverse event reports |
| Overall study start date | 01/08/2022 |
| Overall study end date | 31/12/2035 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 700 |
| Participant inclusion criteria | 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. |
| Participant 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 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 |
| Recruitment start date | 18/09/2023 |
| Recruitment end date | 31/12/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Frimley
Camberley
GU16 7UJ
United Kingdom
Sponsor information
Industry
129 Deerdykes View
Westfield Industrial Estate
Cumbernauld
Glasgow
G68 9HN
Northern Ireland
United Kingdom
| Phone | +44 (0)1236780780 |
|---|---|
| perle10PMCF@gcaesthetics.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2036 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to intellectual property. White paper will shared take home message with additionnal data. |
Editorial Notes
02/11/2023: Ethics approval details added. The protocol/serial number was changed from DM6 640 0101 to DM6 640 103.
02/10/2023: The NCT number has been added.
24/08/2023: Study's existence confirmed by the West of Scotland REC 4.
