Clinical trials: Breast Reconstruction
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
Postoperative Pain, Breast Reconstruction
Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
Transversus Abdominis Plane (TAP) block is a useful tool in pain management after abdominal surgery. It is a regional nerve block that targets T6-L1 thoracolumbar nerves running in the plane between internal oblique and…
- Trial name
- NCT04777591
- Testing
- Liposomal bupivacaine TAP block, Bupivacain
- Where
- 2 sites in United States
- Volunteers
- 117 people
- Sponsor
- University of Virginia
Breast Reconstruction, Breast Cancer
Implementing BREASTChoice Into Practice
Breast reconstruction after mastectomy is a highly personal decision. Although it can restore quality of life for many, there are numerous risks associated with the procedure.
- Trial name
- NCT04491591
- Testing
- Breast Reconstruction Education and Support Tool (BREASTChoice), Attention Control Website, Clinician Survey
- Where
- 2 sites in United States
- Volunteers
- 396 people
- Sponsor
- Washington University School of Medicine
Breast Augmentation, Breast Reconstruction
Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT00905645
- Testing
- Silimed Gel-Filled Mammary Implant
- Where
- United States
- Volunteers
- 1,788 people
- Sponsor
- Tiger Biosciences, LLC.
Breast Hypertrophy, Abdominal Elastosis
Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure
Purpose: The aims of this randomized clinical trial are: 1. to assess scar quality from the patient and surgeon perspectives 2. to assess patient comfort in the days immediately following surgery 3.
- Conditions
- Breast Hypertrophy, Abdominal Elastosis, Breast Reconstruction
- Trial name
- NCT00727025
- Testing
- wound closure device (Steri-Strip™)
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Breast Reconstruction, Anesthesia
Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction
This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients…
- Conditions
- Breast Reconstruction, Anesthesia, Transverse Abdominis Plane Block
- Trial name
- NCT03700970
- Testing
- Liposomal bupivacaine, Regular bupivacaine
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Vanderbilt University Medical Center
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
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 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
Surgery, Breast Reconstruction
Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery
The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia technique ( interfascial block at the serratus muscle) performed in patient undergoing breast surgery and the effect of this technique on…
- Trial name
- NCT02905149
- Testing
- Serrato, Control
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
Mastectomy and Breast Reconstruction
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy…
- Trial name
- ESSBR (NCT01910298)
- Testing
- Breast Reconstruction, Direct to Implant (DTI) with Strattice™, Two Stage Breast Reconstruction
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 131 people
- Sponsor
- LifeCell
Breast Reconstruction
Becker Continued Access Study
While Core Becker patient follow-up is being completed this Continued Access Study is designed to enroll patients at a limited rate per month to allow for continued physician and patient experience with the device.
- Trial name
- NCT01286870
- Testing
- Mentor Becker 25 Expander/Breast Implant, Mentor Becker 50 Expander/Breast Implant
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Mentor Worldwide, LLC
Breast Reconstruction
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.
- Trial name
- NCT01256502
- Testing
- SERI® Surgical Scaffold
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Sofregen Medical, Inc.
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 Cancer, Breast Reconstruction
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.
- Conditions
- Breast Cancer, Breast Reconstruction, Nipple Reconstruction
- Trial name
- NRC (NCT01216319)
- Testing
- Nipple reconstruction
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cook Group Incorporated
Breast Augmentation, Breast Reconstruction
Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial
The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- CPG (NCT00812097)
- Testing
- Mentor Siltex® Contour Profile Gel Mammary Prosthesis
- Where
- United States
- Volunteers
- 955 people
- Sponsor
- Mentor Worldwide, LLC
Breast Reconstruction, Contour Irregularities
Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts
The purpose of this study is to investigate if there is a relationship between the take of fat grafts with and without ADSCs and the presence of specific surface markers on the cells of the stromal vascular fraction.
- Conditions
- Breast Reconstruction, Contour Irregularities, Volume Insufficiency
- Trial name
- NCT01771913
- Testing
- centrifuged fat graft, ADSCs enriched fat graft
- Where
- Brazil
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Breast Augmentation, Breast Reconstruction
NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01853605
- Testing
- Anatomically shaped silicone gel-filled breast implants
- Where
- United States
- Volunteers
- 3,811 people, healthy volunteers welcome
- Sponsor
- Allergan
Transversus Abdominis Plane (TAP) Block Catheter, DIEP or Free MS-TRAM Breast Reconstruction
TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT
Breast reconstruction using a patient's own abdominal tissue is one of the most common methods for restoring mastectomy defects for breast cancer patients.
- Conditions
- Transversus Abdominis Plane (TAP) Block Catheter, DIEP or Free MS-TRAM Breast Reconstruction, Local Pain Management, Abdominal/ Donor Site
- Trial name
- NCT01398982
- Testing
- Bupivacaine (study group), Isotonic saline (control group)
- Where
- Canada
- Volunteers
- 93 people
- Sponsor
- University Health Network, Toronto
Breast Augmentation, Breast Reconstruction
A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
At a national level of 15%, the reoperation rate following augmentation mammaplasty is too high. We are conducting a survey to examine the pre-operative methods by which plastic surgeons determine implant volume, size, shape and…
- Trial name
- NCT00684749
- Where
- United States
- Volunteers
- 142 people
- Sponsor
- University of Minnesota