Clinical trials: Breast Augmentation
Hypomastia, Primary Breast Augmentation
3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery
The purpose of this trial is to evaluate the impact of incorporating three-dimensional (3D)imaging during preoperative consultation on patient reported outcomes in primary breast augmentation surgery.
- Trial name
- NCT01964105
- Testing
- 3D Imaging
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Washington University School of Medicine
Pain, Acute, Nausea
Enhanced Recovery Strategies in Elective Breast Surgery
Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return…
- Conditions
- Pain, Acute, Nausea, Vomiting, Postoperative, Opioid Use
- Trial name
- NCT03187080
- Testing
- Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Enhanced recovery after breast surgery (ERABS) strategies, Paravertebral block using local anesthetic
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Breast Augmentation
European New Texture Implant Clinical Experience With Round Breast Implants
The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation.
- Trial name
- NCT01639742
- Testing
- New texture round breast implants
- Where
- 4 sites in Germany, Sweden and 1 more
- Volunteers
- 18 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
Scar, Surgical Scar
Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars.
- Conditions
- Scar, Surgical Scar, Cicatrix, Cicatrix, Hypertrophic
- Trial name
- NCT01789346
- Testing
- 532nm KTP, 595nm PDL
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cutera Inc.
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.
Pain
Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation
The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation.
- Trial name
- NCT00813111
- Testing
- SKY0402, Bupivacaine HCl
- Where
- 15 sites in United States
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Pacira Pharmaceuticals, 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
Musculoskeletal Pain
Study to Evaluate EB-001 in Reducing Musculoskeletal Pain
To determine the safety and efficacy of single intra-operative treatment of EB-001 IM injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with subpectoral implants
- Trial name
- NCT03193593
- Testing
- EB-001
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Bonti, Inc.
Outpatient Breast Surgery, Mastopexy
Serratus Plane Block for Postoperative Pain Control
This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery.
- Conditions
- Outpatient Breast Surgery, Mastopexy, Augmentation, Revision
- Trial name
- NCT02865928
- Testing
- Bupivicaine HCl, Normal Saline
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Northwell Health
Postoperative Pain
Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty
The primary objective of this study was to demonstrate the superiority of SKY0402 over conventional, commercially-available bupivacaine HCl with respect to the duration of the analgesic effect achieved by a single local…
- Trial name
- NCT01206608
- Testing
- SKY0402 + bupivacaine HCl, Mid-dose SKY0402 + bupivacaine HCl
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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 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
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
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, Breast Augmentation
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- NCT00753922
- Testing
- Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
- Where
- United States
- Volunteers
- 1,008 people
- Sponsor
- Mentor Worldwide, LLC
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
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
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
Postoperative Pain
Phase 2B Upper Extremity Nerve Block Study
This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of…
- Trial name
- NCT03011333
- Testing
- HTX-011, Bupivacaine HCl without epinephrine
- Where
- 2 sites in United States
- Volunteers
- 243 people
- Sponsor
- Heron Therapeutics