Clinical trials: Mammaplasty
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
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.
Scar Formation
Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery
The primary objective of this study is to assess whether intradermal injections of GBT009 along full thickness incisions following surgery results in an improvement in scar appearance.
- Trial name
- NCT01053897
- Testing
- GBT009
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Garnet BioTherapeutics, 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 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 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, 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 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 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 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.
Macromastia
Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures.
- Trial name
- NCT00558246
- Testing
- Dermabond Protape (Prineo), Suture
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 79 people
- Sponsor
- Ethicon, Inc.
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 Ptosis, Obesity
Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.
- Trial name
- NCT00959374
- Testing
- V-Loc 180/90 Wound Closure Device, 3-0 Monocryl Absorbable Sutures
- Where
- 8 sites in United States, Germany
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Breast Cancer
Immediate Postmastectomy Breast Reconstruction (Strattice Breast)
This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with…
- Trial name
- NCT00619762
- Testing
- LTM - a porcine-based surgical mesh
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- LifeCell
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
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
Soft Tissue Support and Repair
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
- Trial name
- NCT01389232
- Testing
- SeriScaffold® Surgical Scaffold
- Where
- 5 sites in Germany, Italy and 2 more
- Volunteers
- 104 people
- Sponsor
- Sofregen Medical, Inc.
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round 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
- NCT00689871
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 715 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Breast Cancer
AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
This study is designed to allow existing investigators continued access to the AeroForm Tissue Expander to treat patients while AirXpanders completes a marketing application and during the review process by FDA.
- Trial name
- XPAND-II (NCT02504424)
- Testing
- AeroForm Tissue Expander
- Where
- 8 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- AirXpanders, 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.