Clinical trials: Breast Implant
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
Contraception, Breastfeeding
Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration and to explore women's experiences with and attitudes towards contraceptive and…
- Conditions
- Contraception, Breastfeeding, Postpartum Contraception
- Trial name
- NCT02866279
- Testing
- Etonogestrel Contraceptive Implant
- Where
- United States
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Contraception
BLIS - Breastfeeding Levonorgestrel IUD Study
We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to…
- Trial name
- BLIS (NCT01990703)
- Testing
- Levonorgestrel IUD
- Where
- 2 sites in United States
- Volunteers
- 285 people
- Sponsor
- University of Utah
Breast Augmentation
European New Texture Implant Clinical Experience With Shaped Breast Implants
The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.
- Trial name
- NCT01639755
- Testing
- new texture shaped breast implants
- Where
- 2 sites in Sweden
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Allergan
Spinal Tumor
A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
The goal of the first part of this clinical research study is to learn how to deliver more accurate radiation treatment of tumors in the spine.
- Trial name
- NCT01624220
- Testing
- Spinal SBRT (Standard Dose), Spinal SBRT (Higher Dose), Gold Seed Implantation
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- M.D. Anderson Cancer Center
Breastfeeding, Contraception
Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women
The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women.
- Trial name
- NCT00828542
- Testing
- etonogestrel implant, depot medroxyprogesterone acetate
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
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 Implantation
Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)
- Trial name
- RANBI (NCT02132572)
- Testing
- BIOCELL™ Textured 410 Implant
- Where
- 5 sites in France, Germany and 3 more
- Volunteers
- 201 people
- Sponsor
- Allergan
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 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
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 Cancer
Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions
The purpose of this study is to determine if a radiation treatment called "Multi-beam Intensity Modulated Radiation Therapy"(IMRT) can reduce side effects related to your implant if they are a candidate for radiation therapy.
- Trial name
- NCT02086578
- Testing
- Breast MRI, Breast-Q© questionnaire, Multi-Beam IMRT
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Post-operative Pain
A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
The investigators hypothesize that in mastectomy patients with breast reconstruction, the addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the acute and chronic setting, compared to…
- Trial name
- NCT02044302
- Testing
- Bupivacaine, Botulinum Toxins, Analgesics
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Yale University
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.
Implant Capsular Contracture
Chemically Assisted Capsulectomy-A New Clinical Approach
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.
- Trial name
- NCT00758667
- Testing
- Mesna
- Volunteers
- 20 people
- Sponsor
- Vanderbilt University
Patient and Surgical Related Risk Factors for Complications
TiLoop® Bra for Breast Reconstruction
A new approach for single stage implant based breast reconstruction (BR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM).
- Trial name
- NCT01544023
- Volunteers
- 207 people
- Sponsor
- University of Rostock
Perfusion; Complications
The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems
This is a randomized study using a variety of techniques to compare and examine blood flow to the remaining skin after mastectomy. All treatments being used are considered standard of care and are not experimental.
- Trial name
- NCT03716050
- Testing
- Nitroglycerin, Negative Pressure Wound Therapy/ Wound VAC, Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Wake Forest University Health Sciences