Clinical trials: Breast Augmentation
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 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
Postoperative Pain
Observational Study to Assess Long-Term Follow-Up of Breast Augmentation Subjects
A history and physical focused on clinical sequelae of breast implant rupture was completed by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon shell.
- Trial name
- NCT01076686
- Testing
- Questionnaire and Physical Exam
- Volunteers
- 94 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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
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
Postoperative Pain
Bupivacaine HCl PK and Safety in Augmentation Mammoplasty
This is a Phase 4, randomized, open-label study of bupivacaine HCl administered either by instillation into the surgical site or by injection into the surgical site in subjects undergoing bilateral submuscular augmentation…
- Trial name
- NCT03705065
- Testing
- Bupivacaine HCl
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Heron Therapeutics
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
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
Pain
Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery
The goal of the clinical study was to see if applying low level laser light therapy to the breasts during breast implant surgery could lessen pain experienced by 24 hours after the surgery.
- Trial name
- NCT00926887
- Testing
- Erchonia(R) EML Laser
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Erchonia Corporation
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
Mammoplasty, Postoperative Pain
Study of EXPAREL in Patients Undergoing Breast Augmentation
This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).
- Trial name
- NCT01582490
- Testing
- Instillation - EXPAREL, Infiltration - EXPAREL
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Pacira Pharmaceuticals, Inc