Clinical trials: Mammaplasty
Breast Implants
Study of the Safety and Effectiveness of Motiva Implants®
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.
- Trial name
- NCT03579901
- Testing
- Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
- Where
- 29 sites in United States, Germany and 1 more
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Reconstructive Surgical Procedures
The SurgiMend PRS Retrospective Study
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
- Trial name
- NCT05182177
- Testing
- SurgiMend PRS
- Where
- 6 sites in Italy, Switzerland and 1 more
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
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
Reconstructive Surgical Procedures
DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.
Patients selected for DIEP breast reconstruction were examined with preoperative CTA, Doppler Ultrasound, dynamic infrared thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) for perforator mapping.
- Trial name
- NCT04115995
- Testing
- Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)
- Where
- Norway
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University Hospital of North Norway
Surgical Site Infection, Surgical Complication
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Goal of the Clinical Trial: The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections…
- Conditions
- Surgical Site Infection, Surgical Complication, Implant Infection, Implant Complication
- Trial name
- NCT06649890
- Testing
- Xperience™ Advanced Surgical Irrigation, Dilute Povidone-Iodine
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Perioperative Fluid Management
Comparison of Hemodynamic Results of Two Different Fluid Managements
In the reduction mammoplasty operations performed in the Plastic and Reconstructive surgery operating room in our clinic, the female patient group, who does not have co-morbidities and does not exceed middle age, is followed by…
- Trial name
- NCT05733403
- Testing
- isotonic solution, Noradrenaline
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Istanbul University
Mammaplasty
The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery
This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery.
- Trial name
- NCT05171179
- Testing
- Breast Reconstruction (Mammaplasty), Pecs blocks, Exparel
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Opioid Use, Pain, Postoperative
Pain in Breast Surgery Intervention
This study will be a randomized control trial providing an educational component to study participants and a pre-operative and post-operative survey with a goal to show an improvement in pain control, decrease in narcotic use…
- Trial name
- NCT04058938
- Testing
- Educational handout instrument, Control
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
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
Breast Cancer
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy.
- Trial name
- AllodermRCT (NCT00956384)
- Testing
- One-stage dermal matrix/implant procedure, Two-stage tissue expander/implant procedure
- Where
- 4 sites in Canada
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Breast Neoplasms, Fibrocystic Disease of Breast
Involvement of Endogenous Digitalis-like Compounds in Breast Cancer
The endogenous digitalis-like compounds (DLC)are steroid hormones synthesized and released from the adrenal gland.They are integrated in the feed-back system of the Hypothalami-Pituitary-Adrenal gland axis.One of their remarkable…
- Conditions
- Breast Neoplasms, Fibrocystic Disease of Breast, Mammaplasty
- Trial name
- NCT00310882
- Where
- Israel
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
Breast Augmentation, Breast Reconstruction
Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.
- Trial name
- EMMIE (NCT03386682)
- Testing
- ESTYME® MATRIX Breast Implants
- Where
- 8 sites in France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Symatese Aesthetics
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 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 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 After Mastectomy, Breast Neoplasm
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra…
- Conditions
- Breast Reconstruction After Mastectomy, Breast Neoplasm, Breast Cancer, Breast Diseases
- Trial name
- PRO-Pocket (NCT03868514)
- Testing
- TiLOOP® Bra Pocket
- Where
- 12 sites in Austria, Germany
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
Free Tissue Flaps
Detection of Flap Ischemia Using Interstitial Glucose Monitor
A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an adjunct to the current monitoring method - would be a tremendous improvement in detection of early postoperative flap ischemia and, in…
- Trial name
- NCT02604069
- Testing
- Continuous Glucose Monitor
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Hamilton Health Sciences Corporation
Breast Augmentation, Breast Reconstruction
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants
- Trial name
- NCT07679594
- Testing
- Breast augmentation surgery, Breast reconstruction surgery
- Where
- 2 sites in France, Spain
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- GCA (Eurosilicone)
Sensation Disorders, Sensation, Phantom
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and…
- Conditions
- Sensation Disorders, Sensation, Phantom, Pain, Postoperative, Pain, Chronic
- Trial name
- NCT06094257
- Testing
- Sensory testing
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Breast Reconstruction Surgery
Distance Healing in Wound Healing
This trial examines the impact of patients' knowledge of an experienced distant healer's efforts to heal them on measures of wound healing, psychosocial functioning, and physiological symptoms after plastic surgery.
- Trial name
- NCT00067717
- Testing
- Distance healing
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- California Pacific Medical Center Research Institute