Clinical trials: Mammaplasty
Blood Transfusion, Blood Transfusion, Autologous
A Study to Determine the Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Non-anemic Patients Who Are Undergoing Orthopedic, Heart and Blood Vessel, or Breast Reduction Surgery; Performed in Combination With a Procedure to Reduce Blood Loss During Surgery.
The purpose of this study is to determine the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery (which is shorter than the conventional…
- Conditions
- Blood Transfusion, Blood Transfusion, Autologous, Orthopedic Procedures, Orthopedic Surgery
- Trial name
- NCT00270023
- Testing
- epoetin alfa
- Volunteers
- 112 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Breast Cancer, Breast Reconstruction
Study of AeroForm Tissue Expander for Breast Reconstruction
This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
- Trial name
- ASPIRE (NCT01903174)
- Testing
- AeroForm Breast Tissue Expander
- Where
- Australia
- Volunteers
- 21 people
- Sponsor
- AirXpanders, Inc.
Breast Reconstruction
DuraSorb® in Prosthetic Breast Reconstruction
This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.
- Trial name
- NCT04646057
- Testing
- DuraSorb®
- Where
- 7 sites in United States
- Volunteers
- 168 people
- Sponsor
- Surgical Innovation Associates, Inc.
Mastectomy and Breast Reconstruction
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy…
- Trial name
- ESSBR (NCT01910298)
- Testing
- Breast Reconstruction, Direct to Implant (DTI) with Strattice™, Two Stage Breast Reconstruction
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 131 people
- Sponsor
- LifeCell
Breast Asymmetry Between Native Breast and Reconstructed Breast
Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation
This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast…
- Trial name
- NCT02649283
- Testing
- OrbiSymm device, Breast symmetrisation
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Orbix Medical Ltd.
Breast Augmentation, Mammaplasty
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population.
- Trial name
- NCT06510205
- Testing
- Mentor Breast implants
- Where
- 4 sites in China
- Volunteers
- 6,111 people
- Sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.
Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance
Safety and Performance of Motiva® Sizers
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction
- Trial name
- NCT06274736
- Testing
- Motiva Sizer
- Where
- Costa Rica
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Mammaplasty, Breast Cancer
Motiva Flora® Aesthetic Breast Recon® Clinical Study
The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement…
- Conditions
- Mammaplasty, Breast Cancer, Poland Syndrome
- Trial name
- NCT06146231
- Testing
- Motiva Flora® Tissue Expander
- Where
- 4 sites in Belgium, Colombia and 2 more
- Volunteers
- 66 people
- Sponsor
- Establishment Labs
Breast Cancer
Patient Controlled Tissue Expansion for Breast Reconstruction
This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.
- Trial name
- XPAND (NCT01425268)
- Testing
- AeroForm Tissue Expansion, Saline Tissue Expansion
- Where
- 17 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- AirXpanders, Inc.
Breast Reconstruction, Breast Reconstruction Following Mastectomy
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to…
- Conditions
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation
- Trial name
- PERLE10PMCF (NCT06013514)
- Testing
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- GCA (Eurosilicone)
Mammaplasty, Cicatrix
Juvista (Avotermin) in Breast Reduction Surgery Scars
Severe scarring is a common problem following breast reduction surgery, studies have shown that over 64% of patients develop a hypertrophic scar at three months after the operation.
- Trial name
- NCT00432328
- Testing
- Avotermin
- Where
- 6 sites in United Kingdom
- Volunteers
- 39 people
- Sponsor
- Renovo
Breast Reconstruction
Compassionate Use of the Becker Expander/Breast Implant
To provide access of the Becker Expander/Breast implant to women who do not meet inclusion/exclusion criteria of the Becker Continued Access Study Patients' physician will contact Mentor to request use of the device and each…
- Trial name
- NCT01000012
- Testing
- Becker 50 Expander/Breast implant, Becker 25 Expander/Breast implant
- Where
- United States
- Sponsor
- Mentor Worldwide, LLC
Breast Tissue Accessory, Breast Cancer
Motiva Flora Tissue Expander PMCF
The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of…
- Trial name
- NCT05447988
- Testing
- Breast Tissue Expander
- Where
- 5 sites in Chile, Costa Rica and 2 more
- Volunteers
- 136 people
- Sponsor
- Establishment Labs
Breast Reconstruction, Mammary Reconstruction
A Clinical Study Evaluating the Safety and Performance of Eurosilicone Integrated Valve Tissue Expanders (IVTE)
Patients can undergo breast reconstruction surgery in two stages before implantation of the permanent prosthesis for several reasons.
- Trial name
- NCT07842406
- Testing
- Breast reconstruction surgery
- Volunteers
- 100 people
- Sponsor
- GCA (Eurosilicone)
Primary Breast Augmentation, Primary Breast Reconstruction
Memory Gel and Shape Combined Cohort
The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or…
- Conditions
- Primary Breast Augmentation, Primary Breast Reconstruction, Revision Breast Augmentation, Revision Breast Reconstruction
- Trial name
- Glow (NCT02919592)
- Testing
- MemoryShape® Breast Implants, MemoryGel® Breast Implants, Other Aesthetic Surgery
- Where
- 78 sites in United States
- Volunteers
- 3,603 people
- Sponsor
- Mentor Worldwide, LLC
Deep Inferior Epigastric Perforator Flap Reconstruction
Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure
To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator…
- Trial name
- NCT03481140
- Testing
- TissuGlu Surgical Adhesive
- Volunteers
- 58 people
- Sponsor
- Cohera Medical, Inc.
Breast Reconstruction
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.
- Trial name
- NCT02033590
- Testing
- Biodegradable (purified) surgical silk scaffold
- Sponsor
- Sofregen Medical, Inc.
Breast Reconstruction Surgery
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.
- Trial name
- NCT06556654
- Testing
- TRBR Device
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- W.L.Gore & Associates
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