Clinical trials: Reconstructive Surgical Procedures
Anterior Cruciate Ligament Reconstruction
Iovera° to Treat Pain Associated With ACL Reconstruction and Rehabilitation
To evaluate the outcomes of patients undergoing iovera° treatment of the ISN and AFCN on postoperative knee pain and function following anterior cruciate ligament reconstruction
- Trial name
- NCT03688477
- Testing
- iovera°
- Where
- United States
- Sponsor
- Pacira Pharmaceuticals, Inc
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 Cancer
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
- Trial name
- NCT01959867
- Testing
- SurgiMend® PRS, No Intervention
- Sponsor
- Integra LifeSciences Corporation
Ventral Hernia
Hernia Repair in Multiply Morbid Patients
Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence.
- Trial name
- RAM2P (NCT00930787)
- Testing
- Strattice Reconstructive Tissue Matrix (Hernia Repair), Proceed Surgical Mesh (Hernia repair)
- Where
- 13 sites in United States
- Volunteers
- 23 people
- Sponsor
- LifeCell
Breast Augmentation, Breast Reconstruction
Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT00905645
- Testing
- Silimed Gel-Filled Mammary Implant
- Where
- United States
- Volunteers
- 1,788 people
- Sponsor
- Tiger Biosciences, LLC.
Skin Necrosis, Breast Reconstruction
B4P Trial - BLOOM43 for Preconditioning
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer.
- Conditions
- Skin Necrosis, Breast Reconstruction, Breast Surgery
- Trial name
- NCT07340632
- Testing
- BLOOM43
- Volunteers
- 60 people
- Sponsor
- Plexaa Ltd
Surgery, Gastric Cancer
Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation
By uploading pre-operative patient information and patient CT data to RUS™, a virtual surgical environment with patient-specific relief prediction models can be provided.
- Trial name
- NCT05039333
- Testing
- RUS(TM) software : surgical navigation
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Hutom Corp
Breast Augmentation, Breast Reconstruction
Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial
The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- CPG (NCT00812097)
- Testing
- Mentor Siltex® Contour Profile Gel Mammary Prosthesis
- Where
- United States
- Volunteers
- 955 people
- Sponsor
- Mentor Worldwide, LLC
Heart Defect, Congenital
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract…
- Trial name
- Xplore2 (NCT03022708)
- Testing
- Xeltis Bioabsorbable Pulmonary Valved Conduit
- Where
- 10 sites in United States, Bulgaria and 2 more
- Volunteers
- 6 people
- Sponsor
- Xeltis
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
Tumor, Facial Fracture
A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.
This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.
- Conditions
- Tumor, Facial Fracture, Mandibular Fractures, Fibrous Dysplasia
- Trial name
- NCT04931056
- Testing
- Titanium Facial Plates, Titanium Mandibular Plates, Add-on Condyle
- Where
- Argentina
- Volunteers
- 91 people
- Sponsor
- Zimmer Biomet
Aortic Arch Disease
Prospective, Multicenter, Single-Arm Study of Aortic Arch Pathology Reconstruction
A prospective ,multiple center Study about the Safety and Efficacy of the Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd., in patients with…
- Trial name
- NCT07139912
- Testing
- Thoracic Aortic Multi-Branch Stent Graft System
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
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
Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection
Myriad™ Augmented Soft Tissue Reconstruction Registry
This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures.
- Conditions
- Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus
- Trial name
- MASTRR (NCT05243966)
- Testing
- Myriad Matrix™ and Myriad Morcells™
- Where
- 15 sites in United States
- Volunteers
- 800 people
- Sponsor
- Aroa Biosurgery Limited
Ear Deformities, Acquired, Ear; Deformity, Congenital
Evaluation of the Auryzon Devices in the Optimization of Ear and Nose Reconstruction Procedures
This study evaluates the efficacy of the AuryzoN devices in the ear and nose reconstruction surgeries, both in terms of operative time and overall quality of reconstruction.
- Conditions
- Ear Deformities, Acquired, Ear; Deformity, Congenital, Microtia, Nose Deformity
- Trial name
- NCT03624608
- Testing
- AuryzoN Family of Devices
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Reconstrata, LLC
Anterior Cruciate Ligament Injuries
Jewel ACL Post Market Clinical Follow Up Study
The objective of the study is to assess re-rupture rates and patient outcomes from subjects with at least 5 year follow up, treated with the JewelACL device for ACL reconstruction.
- Trial name
- NCT04580290
- Testing
- JewelACL
- Where
- Poland
- Volunteers
- 120 people
- Sponsor
- Xiros Ltd
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.
Acetabulum Fracture, Pelvic Ring Fracture
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System
The study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Reconstruction System…
- Trial name
- NCT05215626
- Where
- Italy
- Volunteers
- 78 people
- Sponsor
- Zimmer Biomet
Breast Reconstruction
DuraSorb® in Prosthetic Breast Reconstruction
This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.
- Trial name
- NCT04646057
- Testing
- DuraSorb®
- Where
- 7 sites in United States
- Volunteers
- 168 people
- Sponsor
- Surgical Innovation Associates, Inc.
Aneurysms
A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms
A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
- Trial name
- STERLING (NCT03642639)
- Testing
- MICRUSFRAME and GALAXY coils
- Where
- 51 sites in United States, Belgium and 8 more
- Volunteers
- 723 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.