Clinical trials: Breast Augmentation
Breast Augmentation
Swedish Macrolane Registry
A Registry to monitor long term safety in female subjects after treatment with Macrolane VRF20 and/or MacrolaneT VRF30 in the breasts.
- Trial name
- NCT01145235
- Where
- Sweden
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
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
Pain, Postoperative, Anesthesia; Regional
The Pectoral Block for Breast Augmentation Surgery
The pectoral block is a recently developed regional anesthetic technique that can be used for the treatment of postoperative pain after breast surgery.
- Trial name
- BPCAM (NCT03040167)
- Testing
- PEC 1 block, Bupivacaine with epinephrine, Normal saline
- Where
- 2 sites in Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Pierre Beaulieu
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 Implant
Motiva Implants® Post-Approval Study
This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.
- Trial name
- Motiva PAS (NCT06938399)
- Testing
- Silicone gel-filled breast implants - Motiva Implants®, Aesthetic Surgery
- Where
- 33 sites in United States
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Breast Augmentation, Breast Reconstruction
Sientra Post-Approval Study
This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01639053
- Where
- United States
- Volunteers
- 5,498 people, healthy volunteers welcome
- Sponsor
- Tiger Biosciences, 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.
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 Cancer, Breast Surgery
Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery
The goal of this study is to develop a questionnaire to measure patient satisfaction with their breast surgery. This questionnaire will help surgeons better understand how patients feel about their surgical results.
- Conditions
- Breast Cancer, Breast Surgery, Breast Reconstruction, Breast Reduction
- Trial name
- NCT00605670
- Testing
- questionnaires
- Where
- 5 sites in United States, Canada
- Volunteers
- 722 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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.
Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast…
- Conditions
- Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III, Capsular Contracture Grade IV
- Trial name
- STANCE (NCT05945329)
- Testing
- GalaFLEX LITE™ Scaffold, Standard surgery
- Where
- 37 sites in United States
- Volunteers
- 250 people
- Sponsor
- C. R. Bard
Breast Diseases
MAC vs TIVA Ambulatory Breast Augmentation
hypothesis: the combination of LA with remifentanil and ketofol [monitored anesthesia care (MAC)] for ambulatory breast augmentation may result in results in better QoR on day of surgery as compared with total i.v.
- Trial name
- NCT03764267
- Testing
- Remifentanil, general anesthetic
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
Plastic Surgery
Usefullness of Peri-operative Tranexamic Acid in Primary Breast Augmentation With Implants.
Tranexamic acid (TXA), as an antifibrinolytic agent, has shown a tremendous interest in surgery by reducing blood loss ; but only few articles have been reported in the plastic surgery scope.
- Trial name
- DRAINAGE (NCT03364569)
- Testing
- Tranexamic acid
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Hôpital NOVO
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
Breast Implants, Surgery, Plastic
Breast Augmentation Rehabilitation Program
The purpose of this study is to determine whether implementing a rehabilitation program can improve the post-operative time to pain free living after breast augmentation.
- Trial name
- NCT01857765
- Testing
- Rehabilitation, Follow-up
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of British Columbia
Breast Augmentation, Fat Grafting
A Prospective Study of Autologous Fat Grafting for Breast Augmentation
This research study is to evaluate the natural history of fat transplanted from a person's body to their breasts. We are seeking a natural, safe, and effective alternative to breast implants.
- Trial name
- NCT00663156
- Testing
- breast implants, Liposuction, fat grafting
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Georgetown University
Breast Augmentation
Improved Breast Enlargement Using the Subject's Own Fat Tissue
The goal of this clinical study is to learn if the Medical Device Under Investigation (simply "the device") is safe to use in human adults undergoing breast augmentation surgery.
- Trial name
- SWIFT (NCT07869641)
- Testing
- An injectable, biodegradable hydrogel, in reconstitution medium, Reconstitution medium
- Where
- 2 sites in Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- 4Tissue
Mammoplasty
Dual-Plane Breast Augmentation: Axillary Approach With Assistant of Endoscope
The purpose of this study is to evaluate the feasibility and outcome of performing dual plane breast augmentation with assistant of endoscope by axillary approach.
- Trial name
- NCT00505557
- Testing
- Transaxillary dual plane technique
- Where
- China
- Sponsor
- Chinese Academy of Sciences
Mammaplasty, Mastectomy
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro…
- Conditions
- Mammaplasty, Mastectomy, Lumpectomy
- Trial name
- NCT00466765
- Testing
- Brava Autologous Fat Transfer System
- Where
- 2 sites in United States
- Volunteers
- 589 people, healthy volunteers welcome
- Sponsor
- Brava