Clinical trials: Reconstructive Surgery
- Condition Reconstructive Surgery
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
Safety and Performance, Breast Tissue Expander
Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction
The study investigates the safety and performance of Silimed® brand breast tissue expander in women born with indication for breast reconstruction.
- Trial name
- STEPS-R (NCT06981481)
- Testing
- Breast tissue expander
- Where
- 3 sites in Brazil
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
Precise Image (AI Reconstruction Feature of CT 5400 RT System)
Clinical Study of CT 5400 RT for Precise Image Validation
The purpose of this study is to evaluate the effectiveness of the Precise Image (PI), an AI feature of CT 5400 RT System
- Trial name
- NCT06589934
- Testing
- Precise Image
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
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)
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
Congestive Heart Failure, Ischemic Cardiomyopathy
Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity
The purpose of the present prospective, randomized study is to investigate the clinical effectiveness of standardized left ventricular reconstruction surgery (LVR).
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Coronary Artery Disease, Myocardial Diseases
- Trial name
- NCT00326690
- Testing
- Blue Egg Device
- Where
- 10 sites in United States, Germany
- Volunteers
- healthy volunteers welcome
- Sponsor
- BioVentrix
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.
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
Anterior Cruciate Ligament Tear
Bridge-Enhanced ACL Repair vs ACL Reconstruction
The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.
- Trial name
- NCT02664545
- Testing
- BEAR Scaffold, Tendon Graft
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Miach Orthopaedics
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
Electrocardiography (ECG), Photoplethysmography
Synchronised ECG and PPG Data Collection for AI-based QT/QTc Reconstruction (ILECS-ECGPPG)
This observational study will collect synchronized photoplethysmography (PPG) and electrocardiogram (ECG) recordings from approximately 50 healthy adult volunteers.
- Conditions
- Electrocardiography (ECG), Photoplethysmography, Healthy Volunteers
- Trial name
- ILECS-ECGPPG (NCT07684807)
- Testing
- Corsano CardioWatch 287-2, VivaLNK wearable ECG patch
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Corsano Health B.V.
Breast Augmentation, Breast Reconstruction
Sientra Post-Approval Study
This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01639053
- Where
- United States
- Volunteers
- 5,498 people, healthy volunteers welcome
- Sponsor
- Tiger Biosciences, LLC.
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
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
Posterior Fossa Hemorrhage, Lung Cancer
Pilot Study of Model Based Iterative Reconstruction Using 64-Slice
This study is being performed to confirm that the new technique, Model-Based Iterative Reconstruction (MBIR) with reduced radiation dose can deliver equivalent image quality for CT scans compared to current techniques (Filtered…
- Conditions
- Posterior Fossa Hemorrhage, Lung Cancer, Flank Pain, Urolithiasis
- Trial name
- MBIR (NCT01431378)
- Where
- 3 sites in United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
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
Mammaplasty, Mastectomy
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro…
- Conditions
- Mammaplasty, Mastectomy, Lumpectomy
- Trial name
- NCT00466765
- Testing
- Brava Autologous Fat Transfer System
- Where
- 2 sites in United States
- Volunteers
- 589 people, healthy volunteers welcome
- Sponsor
- Brava
Volunteers
Clinical Study of Spectral CT Verida
This study will prospective enroll 80 subjects to evaluate the comparison of image quality, proportion of high-quality images, and image noise between the Spectral Precise Image (SPI) intelligent denoising for low-dose scans on…
- Trial name
- NCT07759011
- Testing
- CT Radiation Scan
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
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 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