Clinical trials: Breast Reconstruction
Recurrent Ptosis of the Breast
Seri Surgical Scaffold Support of the Lower Pole of the Breast
Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or…
- Trial name
- SeriSupport (NCT02016612)
- Testing
- Seri Surgical Scaffold
- Where
- 2 sites in United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Bengtson Center
Breast Hypertrophy
Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty
Main research question: Is vertical scar reduction mammoplasty superior when compared to inferior pedicle reduction mammoplasty in terms of patient quality of life and cost-effectiveness? Why is this research important?: There is…
- Trial name
- NCT00149344
- Testing
- Vertical scar versus inferior pedicle reduction mammoplasty
- Where
- Canada
- Volunteers
- 254 people, healthy volunteers welcome
- Sponsor
- McMaster University
Breast Cancer
Intraoperative Pathway in DIEP Flap Breast Reconstruction
Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric…
- Trial name
- NCT00543764
- Testing
- pathway
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Breast Cancer
Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant
The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or augmentation
- Trial name
- NCT01711710
- Testing
- Cohesive Gel Breast Implant
- Where
- 2 sites in South Korea
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
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
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
Macromastia (Symptomatic)
Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following…
- Trial name
- NCT01404351
- Testing
- PEAK PlasmaBlade, Scalpel and Traditional Electrosurgery
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medtronic Surgical Technologies
Breast Reconstruction, Patient Education
Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster
This pilot study uses a randomized controlled trial design to introduce an educational session for breast reconstruction patients. Participants will be randomly assigned to the (1) control group or the (2) experimental group.
- Trial name
- RESTORE (NCT03743753)
- Testing
- Experimental
- Where
- 2 sites in Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- McMaster University
Mammoplasty Patient
REVOLVE or PureGraft Technique in Processing Fat Grafts for Patients Undergoing Breast Reconstruction
This trial studies how well REVOLVE or PureGraft technique works in processing fat grafts for patients who are undergoing breast reconstruction.
- Trial name
- NCT03502512
- Testing
- Questionnaire Administration, Reconstructive Surgery
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Mastectomy, Mastectomy Patient
A Study on Pain After Breast Reconstruction
The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer.
- Conditions
- Mastectomy, Mastectomy Patient, Mastectomy and Breast Reconstruction, Breast Reconstruction
- Trial name
- NCT06627582
- Testing
- PROMIS Scale v2.0 - Pain Intensity 3a, PROMIS 29+2, PROMIS Scale v2.0 - Nociceptive Pain Quality 5a
- Where
- 7 sites in United States
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Memorial Sloan Kettering Cancer Center
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,Hypertrophy, Cost-effectiveness
Cost-effectiveness of Reduction Mammaplasty
Several works show breast hypertrophy as pain cause, postural alterations, dermatitis and decrease of the functional capacity and of the self-esteem.
- Trial name
- NCT00992368
- Testing
- reduction mammaplasty
- Where
- Brazil
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Federal University of São Paulo
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 Complications, Recurrence
Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction
Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with immediate reconstruction.
- Conditions
- Postoperative Complications, Recurrence, Breast Neoplasms, Breast Cancer
- Trial name
- SORI (NCT04108117)
- Testing
- Robotic nipple sparing mastectomy
- Where
- South Korea
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- Severance Hospital
Capsular Contracture Associated With Implant, Foreign-Body Reaction
Experimental and Clinical Investigation of the Implant Surface Roughness Reduction Effect on Early-stage Fibrosis
The goal of this single-center, randomised double-blinded trial is to compare the early stage fibrosis progression around conventional textured expander and the SmoothSilk® expander with reduced surface roughness in women…
- Conditions
- Capsular Contracture Associated With Implant, Foreign-Body Reaction, Wounds and Injuries, Tissue Expander Disorder
- Trial name
- NCT05648929
- Testing
- Patient Satisfaction Questionnaire, Pregnancy test, Blood draw
- Where
- Austria
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Medical University Innsbruck
Breast Cancer
Laser Speckle Imaging During Breast Reconstruction
Around 3500 women a year have surgery to reconstruct a breast/s after cancer. Breast reconstruction can have a positive impact on their lives, but unfortunately 3 or 4 in 10 women have problems with healing after their operation.
- Trial name
- SIMBAR (NCT06523452)
- Testing
- Laser Speckle Imaging
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Royal Devon and Exeter NHS Foundation Trust
Breast Cancer
Cost-Effectiveness of Abdominal-based Autogenous Tissue vs Tissue Expander-Implant Reconstruction - A Feasibility Study
It is estimated that about 25% and 40% of health care expenditures in Canada and USA respectively are wasted because of inefficiencies and not practicing evidence-based medicine.
- Trial name
- NCT02438449
- Testing
- Breast Reconstruction Surgery
- Where
- Canada
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- McMaster University
Breast Cancer
TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction
The aim of the present study is to investigate the effect of intravenous anesthetics versus the administration of volatile anesthetics on stress and pain levels during autologous fat transfer for breast reconstruction in a Day…
- Trial name
- TIVA (NCT04077827)
- Testing
- Propofol
- Where
- Greece
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- National and Kapodistrian University of Athens
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 Cancer, Radiotherapy; Complications
Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients
This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy…
- Trial name
- NCT05253170
- Testing
- Hypofractionation, Conventional Fractionation
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Seoul National University Bundang Hospital