Clinical trials: Reconstructive Surgical Procedure
Peripheral Vascular Diseases
Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels
The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require…
- Trial name
- EXPAND (NCT03720704)
- Testing
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis
- Where
- 11 sites in France, Germany and 3 more
- Volunteers
- 280 people
- Sponsor
- W.L.Gore & Associates
Breast Reconstruction
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.
- Trial name
- NCT01256502
- Testing
- SERI® Surgical Scaffold
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Sofregen Medical, Inc.
Great Vessel Reconstruction, Peripheral Vessel Reconstruction
Post-Market Registry in Europe and US for the Use of VascuCelTM
This is a post-market, multi-centre, open-label registry designed to collect prospective safety and performance data on the use of VascuCel in patients who require great vessel reconstruction, peripheral vascular reconstruction…
- Conditions
- Great Vessel Reconstruction, Peripheral Vessel Reconstruction, Suture Line Buttressing
- Trial name
- VascuCel (NCT04906824)
- Testing
- great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
- Where
- 5 sites in United States, Italy
- Volunteers
- 100 people
- Sponsor
- LeMaitre Vascular
Peri-implantitis
Reconstruction of Peri-implant Osseous Defects: A Randomized Trial
The purpose of this randomized trial was to compare reconstructive surgery of advanced peri-implant intra-osseous defects with porous titanium granules (PTG/Test) to open flap debridement (OFD/Control) in a non-submerged…
- Trial name
- NCT02406001
- Testing
- Tigran PTG, Surgical intervention
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Tigran Technologies AB
Coronary Disease
Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.
- Trial name
- RECON (NCT02073331)
- Where
- 43 sites in United States
- Volunteers
- 1,420 people
- Sponsor
- Elutia Inc.
Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair
GLYCAR Post Market Multicenter Study
Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study
- Conditions
- Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair
- Trial name
- CIP002 (NCT05661981)
- Testing
- GLYCAR Pericardial Patch
- Where
- 4 sites in France, Germany
- Volunteers
- 110 people
- Sponsor
- GLYCAR SA (Pty) Ltd
Breast Cancer, Breast Reconstruction
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.
- Conditions
- Breast Cancer, Breast Reconstruction, Nipple Reconstruction
- Trial name
- NRC (NCT01216319)
- Testing
- Nipple reconstruction
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cook Group Incorporated
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
Breast Cancer, Breast Reconstruction
Study of AeroForm Tissue Expander for Breast Reconstruction
This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
- Trial name
- ASPIRE (NCT01903174)
- Testing
- AeroForm Breast Tissue Expander
- Where
- Australia
- Volunteers
- 21 people
- Sponsor
- AirXpanders, Inc.
Anterior Cruciate Ligament Injuries, Posterior Cruciate Ligament Tear
Interference Screw Mectascrew-C Postmarket Study
An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.
- Trial name
- NCT05791656
- Testing
- Mectascrew-C
- Where
- Switzerland
- Volunteers
- 44 people
- Sponsor
- Medacta International SA
Osteonecrosis
MBCP Safety and Performance in the Osteonecrosis of Femur Head
The aim of this pilot study is to evaluate MBCP performance in bone regeneration after osteonecrosis biopsy of the femur head. This technic may prevent the neck of the femur bone weakness following the healthy area drilling…
- Trial name
- NCT00289575
- Testing
- MBCP
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Biomatlante
Mandible Tumor, Mandibular Injuries
Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction
EpiBone-Craniomaxillofacial (EB-CMF) is an autologous, anatomically shaped bone graft created specifically for the patient's defect, using the patients own adipose-derived mesenchymal stem cells.
- Conditions
- Mandible Tumor, Mandibular Injuries, Mandible; Deformity
- Trial name
- EB-CMF (NCT03678467)
- Testing
- EB-CMF
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Epibone, Inc.
Anterior Cruciate Ligament Reconstruction
SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair
A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.
- Trial name
- NCT00775892
- Testing
- SeriACL Device ACL Reconstruction
- Where
- 6 sites in Austria, Belgium and 1 more
- Volunteers
- 30 people
- Sponsor
- Serica Technologies, 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
Peripheral Nerve Injuries
Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction
This study is a registry of general use of Avance Nerve Graft and is intended to evaluate the uses, response rates, and safety of Avance Nerve Graft in the real-life clinical setting.
- Trial name
- RANGER® (NCT01526681)
- Testing
- Processed Human Nerve Graft, Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc., Autogenous Nerve Graft
- Where
- 49 sites in United States, Austria and 2 more
- Volunteers
- 3,126 people
- Sponsor
- Axogen Corporation
Ischemia
Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
The purpose of the study is to understand the relevance of tissue oximetry measures of tissue flaps during surgery and during recovery, and to determine if T-Stat is a reliable and early method of detecting compromised flaps.
- Trial name
- NCT01173133
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Spectros Corporation
Peripheral Nerve Injury, Prostate Cancer
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
The purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer.
- Conditions
- Peripheral Nerve Injury, Prostate Cancer, Radical Prostatectomy, Nerve Reconstruction
- Trial name
- NCT00953277
- Testing
- Processed Human Nerve Tissue Scaffold
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Axogen Corporation
Breast Cancer
Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction
The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months.
- Trial name
- NCT05459064
- Testing
- Motiva Flora TE
- Where
- 2 sites in Belgium, Spain
- Volunteers
- 144 people
- Sponsor
- Establishment Labs
Intracardiac and Septal Defects, Valve and Anulus Repair
Prospective and Non-randomized Registry of CardioCel 3D
Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of…
- Conditions
- Intracardiac and Septal Defects, Valve and Anulus Repair, Great Vessel Reconstruction, Peripheral Vessel Reconstruction
- Trial name
- NCT04175327
- Testing
- CardioCel implantation
- Where
- 6 sites in Germany, Italy and 2 more
- Volunteers
- 200 people
- Sponsor
- LeMaitre Vascular
Pelvic Organ Prolapse
Post-market Clinical Follow-up of the SRS Implant
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant
- Trial name
- NCT05170074
- Where
- 6 sites in Germany
- Volunteers
- 97 people
- Sponsor
- pfm medical gmbh