Clinical trials: Breast Reconstruction
- Condition Breast Reconstruction
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
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
Macromastia (Symptomatic)
Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following…
- Trial name
- NCT01404351
- Testing
- PEAK PlasmaBlade, Scalpel and Traditional Electrosurgery
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medtronic Surgical Technologies
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 Cancer
AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
This study is designed to allow existing investigators continued access to the AeroForm Tissue Expander to treat patients while AirXpanders completes a marketing application and during the review process by FDA.
- Trial name
- XPAND-II (NCT02504424)
- Testing
- AeroForm Tissue Expander
- Where
- 8 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- AirXpanders, 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 Reconstruction After Mastectomy, Breast Neoplasm
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra…
- Conditions
- Breast Reconstruction After Mastectomy, Breast Neoplasm, Breast Cancer, Breast Diseases
- Trial name
- PRO-Pocket (NCT03868514)
- Testing
- TiLOOP® Bra Pocket
- Where
- 12 sites in Austria, Germany
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
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 Augmentation, Mammoplasty
Evaluation of the Clinical Evolution of Breast Increase Using Prostheses
The breasts are paired, superficial organs with relative symmetry. They particularly characterize femininity as an erogenous area, in addition to playing an extremely important role in a woman's body aesthetics.
- Trial name
- NCT06079086
- Testing
- Breast Implants Lifesil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Lifesil
Breast Implant; Complications, Infection or Inflammation
Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal…
- Trial name
- NCT05744414
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AlloSource
Breast Ptosis, Obesity
Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.
- Trial name
- NCT00959374
- Testing
- V-Loc 180/90 Wound Closure Device, 3-0 Monocryl Absorbable Sutures
- Where
- 8 sites in United States, Germany
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
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 Augmentation, Breast Reconstruction
CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)
The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01959880
- Testing
- The Contour Profile Gel (CPG) breast implants
- Where
- United States
- Volunteers
- 1,891 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Breast Reconstruction
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
- Trial name
- NCT00691327
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 84,329 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Skin Barrier to Water Loss, Skin Health
Apple Peptide Complex for Post-Surgical and Aesthetic Skin Recovery
This clinical study evaluates a topical botanical formulation for supporting skin recovery following invasive and non-invasive aesthetic procedures.
- Conditions
- Skin Barrier to Water Loss, Skin Health, Skin Discoloration, Skin Irritation
- Trial name
- APC-SKIN (NCT07807085)
- Testing
- Apple Peptide Complex Post-Aesthetic Care Protocol
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Grow Out Oils Clinical Aromatherapy Company
Breast Augmentation, Breast Reconstruction
NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X-Style and L-Style Breast Implants…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01870869
- Testing
- Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
- Where
- 58 sites in United States
- Volunteers
- 1,951 people, healthy volunteers welcome
- Sponsor
- Allergan
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 Cancer
Patient Controlled Tissue Expansion for Breast Reconstruction
This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.
- Trial name
- XPAND (NCT01425268)
- Testing
- AeroForm Tissue Expansion, Saline Tissue Expansion
- Where
- 17 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- AirXpanders, Inc.
Perfusion; Complications
Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device
This study is designed to evaluate the information provided to the clinicians by the surgical imaging device. It is also to gain insight on the user interface and how "user friendly" it is to the clinician.
- Trial name
- Presygen™ (NCT03715270)
- Testing
- Image surgical area
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Christie Medical Holdings, Inc.
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01785069
- Testing
- Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
- Where
- 29 sites in United States
- Volunteers
- 355 people, healthy volunteers welcome
- Sponsor
- Allergan