Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study

Breast Reconstruction Clinical Trial

— EMMIE  

Official title:

Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the Breast Augmentation and Reconstruction - EMMIE Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03386682
• Other study ID #: Protocol CLIN PMI-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: April 12, 2021

Study information

• Verified date: April 2021
• Source: Symatese Aesthetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.

Description:

The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction at 3 months, 1 year and 2 years post-procedure

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 12, 2021
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Patient will be included if all of the following criteria are met:

1. Subject of between 18 and 65 years old

2. Candidate eligible for :

a. unilateral or bilateral breast augmentation i. general breast enlargement: cosmetic purposes, providing symmetry to opposite breast in case of unilateral surgery ii. surgical correction of various congenital or acquired anomalies such as amastia, aplasia, hypomastia, hypoplasia, asymmetries, Poland's syndrome, ptosis …

b. or immediate or delayed unilateral or bilateral breast reconstruction (for cancer, trauma, surgical loss of breast)

3. Patient signs PIC (Patient Informed Consent) & willing to comply with the protocol assessments and visits follow up

Exclusion Criteria:

Patient will not be included if any of the following conditions exists:

1. Local or systemic infection or abscess anywhere in the body

2. Existing carcinoma or pre-carcinoma of the breast without treatment or mastectomy treatment without appropriate wash out period for chemotherapy at the surgeon discretion

3. Subject with previous tissue expansion

4. Diagnosis of active cancer of any type for augmentation procedure subject

5. Pregnant subject or intending to become pregnant within three (3) months of the implant procedure

6. Subject who had nursed within three (3) months of implant surgery, or still breastfeeding

7. Tissue characteristics determined clinically inadequate or unsuitable by the surgeon (i.e. tissue damage resulting from radiation, inadequate tissue or compromised vascularity, know complication wound healing)

8. Previously implanted subject with a silicone implant or History of failure following cosmetic augmentation or subcutaneous mastectomy

9. History of autoimmune disease such as but not limited to: lupus, scleroderma …

10. Any condition or treatment for any condition which, in the opinion of the physician, may constitute an unwarranted surgical risk (e.g. anaesthesia allergy, high consumption smoking subject …)

11. Anatomic or physiologic abnormality which could result to significant post-operative complications

12. History of sensitivity of foreign materials or known allergy to any component of the ESTYME® MATRIX Silicone Gel-Filled Breast Implant

13. Subject known for alcohol abuse/history

14. Underlying disease (HIV positive Subject, HF (heart Failure), renal insufficiency, diabetes, hypertension, …)

15. Subject with implanted metal or metal devices, history of claustrophobia, or other condition that would make a MRI scan prohibitive

16. Unwilling to undergo any further surgery for revision

17. Subject with willingness that are unrealistic/unreasonable with the risks involved with the surgical procedure

18. Participating into any other clinical study or had participated into a clinical study without appropriate wash out period at the surgeon discretion

19. Subject who has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study

Related Conditions & MeSH terms

• Breast Augmentation
• Breast Reconstruction

Intervention

Device:
• ESTYME® MATRIX Breast Implants
Breast implant surgery in breast reconstruction or breast augmentation

Locations

Country	Name	City	State
France	Centre F.X. Michelet Chu Bordeaux	Bordeaux
France	Chu Pasteur	Nice
France	Clinique BIZET	Paris
France	Clinique des Champs Elysées	Paris
France	Hopital Tenon	Paris
France	Institut du Sein	Paris
France	Clinique Charcot	Sainte-Foy-lès-Lyon
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Symatese Aesthetics	MedPass International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local complications	Evaluation of the safety 3 months post-implantation.; Procedure-related adverse events/complications at 3 months post implant. Main foreseen complications: infection, haematoma, wound healing complication, fluid accumulation, early capsular contracture, rupture, extrusion.	3 months
Primary	Satisfaction of the patient and the surgeon	Evaluation of the performance, 3 months post-implantation; Performance endpoint will be assessed by implant procedure success at 3 months defined as follows: satisfactory procedure duration for the surgeon; satisfactory size of the incision for the surgeon; implant correct placement (absence of visible deformation of the gel, absence of rotation for anatomical implants)	3 months
Secondary	Local complications	Evaluation of the safety, 1 year and two years post-implantation.; Safety endpoint: incidence of all Adverse Events (AE)/Serious Adverse Events (SAEs) @ 1 year and two years post procedure	1 year and 2 years
Secondary	Satisfaction of the patient and the surgeon	Performance endpoints are as follows: global surgeon satisfaction post-procedure assessed by the usability of the device during the procedure (current implant procedure): surgeon comfort level for the insertion/implantation of the prosthesis,; global patient and surgeon satisfaction @ 1 year and 2 years post-procedure	1 year and 2 years