Clinical Research Directory

The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population

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.

Post-market Prospective Clinical Study of Nagor Perle Mammary Implants

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

Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction

This clinical study aims to evaluate the safety and effectiveness of advanced, minimally invasive techniques for breast augmentation and reconstruction. These methods, known as Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, and Maxtopexia + Mia, focus on preserving breast tissue, reducing recovery time, and improving aesthetic outcomes.

Safety and Performance of Motiva® Sizers

The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures. The research will include 133 women, divided into two groups (56 with sizers and 78 without sizers). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica. The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates. After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5) one year. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook.

Effect of Bilateral Rhomboid Intercostal Block on Postoperative Pain After Breast Implant Surgery

This prospective, randomized, single-center, study aims to evaluate the postoperative analgesic effectiveness of bilateral Rhomboid Intercostal Block (RIB) in patients undergoing elective bilateral breast prosthesis surgery. Effective postoperative pain management is essential to improve patient comfort and reduce opioid consumption. Eligible patients aged 18-65 years with ASA physical status I-II will be randomly assigned to either receive ultrasound-guided bilateral RIB block in addition to standard general anesthesia or undergo surgery without any regional block (control group). All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia (PCA) with intravenous tramadol. The primary outcome of the study is total tramadol consumption within the first 24 postoperative hours. Secondary outcomes include postoperative pain scores at predefined time points, time to first analgesic requirement, need for rescue analgesia, incidence of nausea and vomiting, and block-related complications. The results of this study will help determine whether bilateral RIB block provides superior postoperative pain control compared to standard analgesic management alone in bilateral breast prosthesis surgery.