Clinical trials: Implant Breast Reconstruction
Breast Augmentation, Breast Reconstruction
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants
- Trial name
- NCT07679594
- Testing
- Breast augmentation surgery, Breast reconstruction surgery
- Where
- 2 sites in France, Spain
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- GCA (Eurosilicone)
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.
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00689871
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 715 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Breast Cancer Female, Breast Reconstruction
Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
This study is a multicenter, open-label study with both prospective and retrospective components, enrolling up to 120 subjects undergoing breast reconstruction using acellular dermal matrix (ADM).
- Trial name
- SCderm (NCT06555692)
- Testing
- Transplant acellular dermal matrix(ADM)
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- DOF Inc.
Breast Reconstruction, Breast Augmentation
Mentor MemoryGel Post-Approval Study
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional…
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- MGPAS (NCT00756652)
- Testing
- Mentor Silicone Gel-Filled Breast Implants, Saline Breast Implants
- Volunteers
- 42,491 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Breast Cancer Female
Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other…
- Trial name
- SCderm (NCT06553859)
- Testing
- No intervention conducts.
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- DOF Inc.
Reconstructive Surgical Procedures
The SurgiMend PRS Retrospective Study
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
- Trial name
- NCT05182177
- Testing
- SurgiMend PRS
- Where
- 6 sites in Italy, Switzerland and 1 more
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00690339
- Testing
- Style 410 Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 941 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Breast Implants
Study of the Safety and Effectiveness of Motiva Implants®
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.
- Trial name
- NCT03579901
- Testing
- Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
- Where
- 29 sites in United States, Germany and 1 more
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Breast Cancer Female, Breast Cancer Prevent
First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer
This study is a first in human, two-stage single arm non-comparative study of safety and performance. The aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering…
- Conditions
- Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction
- Trial name
- TIDE (NCT05460780)
- Testing
- MATTISSE TEC
- Where
- 3 sites in France, Georgia
- Volunteers
- 50 people
- Sponsor
- Quanta Medical
Breast Augmentation, Breast Reconstruction
Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study
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.
- Trial name
- EMMIE (NCT03386682)
- Testing
- ESTYME® MATRIX Breast Implants
- Where
- 8 sites in France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Symatese Aesthetics
Breast Augmentation, Breast Reconstruction
Sientra Post-Approval Study
This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01639053
- Where
- United States
- Volunteers
- 5,498 people, healthy volunteers welcome
- Sponsor
- Tiger Biosciences, LLC.
Pain, Postoperative, Hernia, Ventral
An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries
This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open…
- Conditions
- Pain, Postoperative, Hernia, Ventral, Abdominoplasty, Hysterectomy
- Trial name
- NCT04785638
- Testing
- INL-001 (bupivacaine hydrochloride) implant
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Innocoll
Mammaplasty, Mastectomy
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro…
- Conditions
- Mammaplasty, Mastectomy, Lumpectomy
- Trial name
- NCT00466765
- Testing
- Brava Autologous Fat Transfer System
- Where
- 2 sites in United States
- Volunteers
- 589 people, healthy volunteers welcome
- Sponsor
- Brava
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 Reconstruction, Revision Breast Reconstruction
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
- Trial name
- Athena (NCT02724371)
- Testing
- Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
- Where
- 30 sites in United States
- Volunteers
- 400 people
- Sponsor
- Mentor Worldwide, LLC
Breast Cancer
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
- Trial name
- NCT01959867
- Testing
- SurgiMend® PRS, No Intervention
- Sponsor
- Integra LifeSciences Corporation
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
Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)
The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding…
- Trial name
- NCT01853436
- Testing
- Strattice™ Reconstructive Tissue Matrix
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- LifeCell
Breast Augmentation and Breast Reconstruction, Mammaplasty
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.
- Conditions
- Breast Augmentation and Breast Reconstruction, Mammaplasty, Breast Augmentation, Tissue Preservation
- Trial name
- NCT07623564
- Testing
- Mia Harmonization, Mia Scarless Lift, Mia Reconstruction
- Where
- Costa Rica
- Volunteers
- 60 people
- Sponsor
- Establishment Labs