Clinical trials: Implant Breast Reconstruction
Breast Neoplasm Female, Complication of Radiation Therapy
Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy
In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication.
- Conditions
- Breast Neoplasm Female, Complication of Radiation Therapy, Breast Implant; Complications
- Trial name
- NCT03730922
- Testing
- Delayed-immediate reconstruction, Delayed reconstruction
- Where
- 8 sites in Denmark
- Volunteers
- 590 people
- Sponsor
- Danish Breast Cancer Cooperative Group
Breast Cancer
Immediate Implant Breast Reconstruction
The purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy
- Trial name
- ISIS (NCT02055937)
- Testing
- immediate implant breast reconstruction
- Where
- France
- Volunteers
- 53 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
Breast Augmentation, Mammaplasty
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.
- Trial name
- NCT06510205
- Testing
- Mentor Breast implants
- Where
- 4 sites in China
- Volunteers
- 6,111 people
- Sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.
Mastectomy; Lymphedema, Breast Cancer
Polyurethan Versus Non-polyurethan Covered Implants in Combination With Radiotherapy
The purpose of this multicenter retrospective cohort study is to determine the effect of radiotherapy on capsular contraction and implant loss rates in patients undergoing prepectoral immediate implant-based breast reconstruction…
- Trial name
- PRExRT (NCT06747065)
- Testing
- Radiotherapy
- Where
- Switzerland
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Basel, Switzerland
Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance
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.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction
- Trial name
- NCT06274736
- Testing
- Motiva Sizer
- Where
- Costa Rica
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Mammaplasty, Breast Cancer
Motiva Flora® Aesthetic Breast Recon® Clinical Study
The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement…
- Conditions
- Mammaplasty, Breast Cancer, Poland Syndrome
- Trial name
- NCT06146231
- Testing
- Motiva Flora® Tissue Expander
- Where
- 4 sites in Belgium, Colombia and 2 more
- Volunteers
- 66 people
- Sponsor
- Establishment Labs
Complications; Breast Prosthesis, Infection or Inflammation
Antibiotics and Tissue Expanders in Breast Reconstruction
This study is a randomized controlled non-blinded double arm study examining the effect of routine postoperative oral antibiotic therapy in preventing postoperative surgical site infections after breast reconstruction.
- Trial name
- NCT01899690
- Testing
- antibiotic
- Sponsor
- Emory University
Breast Reconstruction
The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment.
- Trial name
- REaCT-ADM (NCT03064893)
- Testing
- Alloderm, Dermacell
- Where
- Canada
- Volunteers
- 62 people
- Sponsor
- Ottawa Hospital Research Institute
Breast Reconstruction, Breast Reconstruction Following Mastectomy
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…
- Conditions
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation
- Trial name
- PERLE10PMCF (NCT06013514)
- Testing
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- GCA (Eurosilicone)
Mastectomy
RCT Implant Based Breast Reconstruction
The main objective of this study is to evaluate patients undergoing mastectomy with immediate implant-based breast reconstruction and compare the outcomes of patients who are discharged the day of surgery versus patients who are…
- Trial name
- NCT04558138
- Testing
- Discharge timing
- Where
- United States
- Volunteers
- 123 people
- Sponsor
- University of Colorado, Denver
Breast Reconstruction
Compassionate Use of the Becker Expander/Breast Implant
To provide access of the Becker Expander/Breast implant to women who do not meet inclusion/exclusion criteria of the Becker Continued Access Study Patients' physician will contact Mentor to request use of the device and each…
- Trial name
- NCT01000012
- Testing
- Becker 50 Expander/Breast implant, Becker 25 Expander/Breast implant
- Where
- United States
- Sponsor
- Mentor Worldwide, LLC
Breast Cancer
Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients
The purpose of the study is to find best post-operative rehabilitation protocol after total mastectomy and immediate reconstruction with tissue expander insertion.
- Trial name
- NCT03541161
- Where
- South Korea
- Volunteers
- 115 people
- Sponsor
- Samsung Medical Center
Breast Cancer
Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction
This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with…
- Trial name
- NCT07372339
- Testing
- Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction, Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction
- Volunteers
- 170 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer
Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants.
- Trial name
- NCT00639106
- Testing
- Alloderm, Questionnaires, Without ALLODERM, Questionnaires
- Where
- 3 sites in United States
- Volunteers
- 70 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Implant Infection, Mammoplasty
Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
Breast implants, either cosmetic or reconstructive, are among the most common procedures performed by plastic surgeons. Bacterial infections or biofilms are implicated in the majority of breast implant complications including…
- Trial name
- NCT03213249
- Testing
- Normal saline, Cefazolin, Skin biopsy
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Washington University School of Medicine
Genetic Predisposition, Breast Cancer
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume.
- Trial name
- MRIMOP (NCT03838549)
- Testing
- Prophylactic mastectomy with immediate breast reconstruction
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Montpellier
Primary Breast Augmentation, Primary Breast Reconstruction
Memory Gel and Shape Combined Cohort
The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or…
- Conditions
- Primary Breast Augmentation, Primary Breast Reconstruction, Revision Breast Augmentation, Revision Breast Reconstruction
- Trial name
- Glow (NCT02919592)
- Testing
- MemoryShape® Breast Implants, MemoryGel® Breast Implants, Other Aesthetic Surgery
- Where
- 78 sites in United States
- Volunteers
- 3,603 people
- Sponsor
- Mentor Worldwide, LLC
Breast Cancer, Breast Cancer Female
Microbiome and Association With Implant Infections
The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples.
- Conditions
- Breast Cancer, Breast Cancer Female, Genetic Predisposition to Disease
- Trial name
- NCT05020574
- Testing
- Cephalexin
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of California, San Francisco
Breast Reconstruction
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.
- Trial name
- NCT02033590
- Testing
- Biodegradable (purified) surgical silk scaffold
- Sponsor
- Sofregen Medical, Inc.
Capsular Contractures
Prevention of Capsular Contracture Using Trental and Vitamin E
The main purpose of this research study is to determine if the use of Trental and Vitamin E will decrease the incidence and severity of contractures (shrinking and or hardening of tissue surrounding the implant) associated with…
- Trial name
- NCT01082003
- Testing
- Trental
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Legacy Health System