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| ID | Type | Description | Link |
|---|---|---|---|
| PMS-MTR-202301 | Other Identifier | Johnson & Johnson Medical (Shanghai) Ltd. |
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The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. In addition to safety data, the study will also gather information on postoperative pain and participant satisfaction levels. The objective is to explore customers' clinical experiences and use them as a reference for future product development. The study intends to enroll different number of participants for each license.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mentor Group | Who recieves Mentor breast implants per request |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mentor Breast implants | Device | Mentor breast implants are circular or waterdrop-shaped devices with shells made of successive cross-linked layers of silicone elastomer. The shell is filled with Mentor's proprietary formulation of silicone gel. Mentor breast implants are available in smooth and textured shells, both supplied in sterile form. |
| Measure | Description | Time Frame |
|---|---|---|
| Breast implant related AEs | Post-op 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Pain Scale assessment | Zero means you have no pain, while 10 represents the most intense pain possible. | 1 month after surgery |
| Customer Satisfaction Score measurement | Measured at 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years after surgery Using a 5-point scoring scale, 5 means very satisfied while 1 means very disatisfied. |
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Inclusion Criteria:
Exclusion Criteria:
Per product instruction for use(IFU)
All populations receiving Mentor breast implants
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | +86 15692105615 | ygu51@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Huimin Wu | Shenzhen Junke Medical Cosmetology Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Huamei Zixin Medical Aesthetic Hospital | Recruiting | Chengdu | 610000 | China | ||
The data sharing policy of Johnson & Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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|
| Up to 5 years after surgery |
| Yunnan Huamei Meilai Cosmetology Hospital |
| Recruiting |
| Kunming |
| 650000 |
| China |
| Shenzhen Yixing Medical Cosmetology Hospital | Recruiting | Shenzhen | 518000 | China |
| Shenzhen Junke Medical Cosmetology Clinic | Recruiting | Shenzhen | 519000 | China |