Clinical trials: Breast Surgery
- Condition Breast Surgery
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Scar Prevention
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
- Trial name
- NCT01037413
- Testing
- EXC 001
- Where
- 5 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Fibroadenoma
MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a.
- Trial name
- NCT00147108
- Testing
- ExAblate 2000
- Where
- 5 sites in United States, Japan
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- InSightec
Perfusion; Complications
Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device
This study is designed to evaluate the information provided to the clinicians by the surgical imaging device. It is also to gain insight on the user interface and how "user friendly" it is to the clinician.
- Trial name
- Presygen™ (NCT03715270)
- Testing
- Image surgical area
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Christie Medical Holdings, Inc.
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
Breast Cancer
Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.
This is a multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard…
- Trial name
- RCT (NCT05113927)
- Testing
- Selene
- Where
- 10 sites in United States
- Volunteers
- 613 people, healthy volunteers welcome
- Sponsor
- Perimeter Medical Imaging
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
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
Surgical Scar, Breast Augmentation
Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift.
- Conditions
- Surgical Scar, Breast Augmentation, Abdominoplasty, Face Lift
- Trial name
- NCT03467724
- Testing
- Fractional Radiofrequency (FRF)
- Where
- Spain
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Scars
Treatment of Breast Lift/Reduction Scars
Laser and light treatment for surgical scars following breast lifts/reductions
- Trial name
- NCT05123508
- Testing
- 2940nm and BBL treatment, Non-treatment side (Control)
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sciton
Breast Implant; Complications, Infection or Inflammation
Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal…
- Trial name
- NCT05744414
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AlloSource
Breast Cancer, Radiation Dermatitis
A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer
The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.
- Conditions
- Breast Cancer, Radiation Dermatitis, Erythema
- Trial name
- NCT01597921
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Water-Jel
Macromastia
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
- PRECISE (NCT00986453)
- Testing
- PEAK PlasmaBlade, Traditional Electrosurgery with scalpel
- Where
- 7 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Medtronic Surgical Technologies
Pain, Postoperative
Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo Following Sub Muscular Breast Augmentation
The present study aims to compare the pre-emptive analgesic efficacy of parecoxib 40 mg IV/IM versus placebo on reducing postoperative acute pain following submuscular breast augmentation.
- Trial name
- NCT00435747
- Testing
- PARECOXIB SODIUM
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Gynecomastia
Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
This is a prospective, multi-center, single-blinded, randomized study of up to 10 study subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an adjunct procedure on one side.
- Trial name
- NCT05093049
- Testing
- Renuvion APR System, Gynecomastia Correction Surgery
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Apyx Medical
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
Surgical Scars
Evaluation of the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)
Patients undergoing breast reduction or mastopexy surgery will be screened and recruited for participation in the study. Eligible patients will act as their own control with one breast receiving the active intervention…
- Trial name
- CHITOSCAR (NCT06992960)
- Testing
- ChitoCare® medical Scar Healing Gel (Örsáragel), Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch
- Where
- Iceland
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Primex ehf
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
Pain
Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery
The goal of the clinical study was to see if applying low level laser light therapy to the breasts during breast implant surgery could lessen pain experienced by 24 hours after the surgery.
- Trial name
- NCT00926887
- Testing
- Erchonia(R) EML Laser
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Erchonia Corporation