Clinical trials: Reconstructive Surgical Procedures
- Condition Reconstructive Surgical Procedures
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
Breast Reconstruction
Acellular Dermal Matrix Investigation in Breast Reconstruction
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
- Trial name
- ADMIRE (NCT06456554)
- Testing
- Acellular Dermal Matrix (Cortiva Tissue Matrix)
- Where
- 13 sites in United States
- Volunteers
- 467 people, healthy volunteers welcome
- Sponsor
- RTI Surgical
Breast Augmentation, Breast Reconstruction
NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01853605
- Testing
- Anatomically shaped silicone gel-filled breast implants
- Where
- United States
- Volunteers
- 3,811 people, healthy volunteers welcome
- Sponsor
- Allergan
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 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
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 Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round 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
- NCT00689871
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 715 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
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
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
Augmentation, Reconstruction
Dermal and Subcutaneous Augmentation and Skin Assessment After Fat-, Stem Cell and Scaffold Injections
Investigate the effect of dermal/subcutaneous injection of ASC enriched fat transplant in a protective natural scaffold, designed to sustain the ASC viability after dermal/subcutaneous injection.
- Trial name
- NCT05079243
- Testing
- Scaffold and adipose-derived stromal cell enriched fat grafts
- Where
- 2 sites in Denmark
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Stemform
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
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
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
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.
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
Ulnar/Radial Collateral Ligament Reconstruction, Ligament Repair or Reconstruction
Registry of Arthrex Hand and Wrist Products
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
- Conditions
- Ulnar/Radial Collateral Ligament Reconstruction, Ligament Repair or Reconstruction, Small Bone Fragments and Arthrodesis, Scapholunate Ligament Reconstruction
- Trial name
- NCT05046600
- Testing
- Products listed in cohort description
- Where
- 5 sites in United States
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- Arthrex, Inc.
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
Hyperpronated Foot, Reconstruction Surgeries of the Foot
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of…
- Conditions
- Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle
- Trial name
- NCT04715139
- Testing
- Products listed in Group/Cohort Description
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Arthrex, Inc.
Sinus Implant Reconstruction
Performance and Safety of Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures
The purpose of this study is to evaluate the performance and to monitor the safety of the bone substitute Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in…
- Trial name
- NCT00163605
- Testing
- Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS)
- Where
- 3 sites in Germany
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation
Cardiac
Spectral Precise Image Study for Coronary Artery
This is a single-center, comparative, observational, retrospective data study. Datasets from patients who underwent spectral coronary CT angiography (CCTA) for suspected coronary artery disease (CAD) or other diagnosis needs as…
- Trial name
- NCT07620457
- Testing
- Non-Interventional Study
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global