Clinical trials: Reconstruction
Ruptured Anterior Cruciate Ligaments
Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft
The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft.
- Trial name
- Z-Lig (NCT01245400)
- Testing
- Z-Lig, allograft
- Where
- 6 sites in Belgium, Denmark and 4 more
- Volunteers
- 60 people
- Sponsor
- Aperion Biologics, Inc.
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
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
The aim of this observational, Post-market, Retro-prospective, open, non-randomized, non-comparative, multicentric, European study is to evaluate the safety and performance of the Monobloc® - Silicone SoftOne® breast implants at…
- Trial name
- SOFTONE (NCT07904091)
- Testing
- Breast augmentation, Breast reconstruction
- Where
- 5 sites in France
- Volunteers
- 630 people
- Sponsor
- Laboratoires ARION
Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy
AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction
This is a single-center, retrospective study which will be used to describe and evaluate the effectiveness of AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery…
- Trial name
- NCT06512259
- Testing
- AlloMend® Acellular Dermal Matrix allograft
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- AlloSource
Breast Cancer Female, Breast Reconstruction
Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been…
- Trial name
- ADM (NCT06555614)
- Testing
- Acellular Dermal Matrix(ADM)
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- DOF Inc.
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
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
Digital Nerve Injury, Nerve Injury
Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.
- Conditions
- Digital Nerve Injury, Nerve Injury, Nerve Reconstruction, Nerve Trauma
- Trial name
- FASTR-TEN (NCT06867185)
- Testing
- Brief Electrical Stimulation Therapy, Digital Nerve Repair
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Checkpoint Surgical Inc.
Breast Augmentation and Breast Reconstruction, Mammaplasty
Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction
This clinical study aims to evaluate the safety and effectiveness of advanced, minimally invasive techniques for breast augmentation and reconstruction.
- Conditions
- Breast Augmentation and Breast Reconstruction, Mammaplasty, Breast Augmentation, Tissue Preservation
- Trial name
- NCT07623564
- Testing
- Mia Harmonization, Mia Scarless Lift, Mia Reconstruction
- Where
- Costa Rica
- Volunteers
- 60 people
- Sponsor
- Establishment Labs
Mandibular Fractures, Facial Fracture
Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting.
- Conditions
- Mandibular Fractures, Facial Fracture, Maxilla Fracture, Orthognathic Surgical Procedures
- Trial name
- UPC (NCT07245810)
- Testing
- Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
- Where
- 2 sites in United States
- Volunteers
- 726 people
- Sponsor
- Stryker Craniomaxillofacial
Knee Injuries
Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery.
- Trial name
- NCT00226759
- Testing
- OMS103HP, Vehicle
- Where
- 20 sites in United States, Canada
- Volunteers
- 321 people
- Sponsor
- Omeros Corporation
Congenital Heart Disease, Cardiac Anomaly
Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery
The objective of this postmarket, retrospective, single center study is to evaluate the clinical outcomes of patients who have received PhotoFix® Decellularized Bovine Pericardium (PhotoFix) as a patch within a cardiac surgical…
- Trial name
- Retro-C (NCT05314868)
- Testing
- PhotoFix
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Artivion Inc.
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
Breast Reconstruction
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.
- Trial name
- NCT02033590
- Testing
- Biodegradable (purified) surgical silk scaffold
- Sponsor
- Sofregen Medical, Inc.
Fracture
Anatomical Shoulder™ Fracture PMCF Study
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture System by analysis of standard scoring systems and radiographs.
- Trial name
- NCT02465398
- Testing
- Fracture Shoulder Arthroplasty
- Where
- 3 sites in Germany, Switzerland and 1 more
- Volunteers
- 52 people
- Sponsor
- Zimmer Biomet
Tetrology of Fallot, Pulmonary Stenosis
MASA Valve Early Feasibility Study
The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and…
- Conditions
- Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus, Transposition of Great Vessels
- Trial name
- MVEFS (NCT05452720)
- Testing
- Surgical Right Ventricular Outflow Tract Reconstruction
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- PECA Labs
Abdominal Wall Defect, Abdominal Wall Injury
Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma…
- Conditions
- Abdominal Wall Defect, Abdominal Wall Injury, Abdominal Hernia
- Trial name
- PMCF_AWR (NCT04580511)
- Testing
- CELLIS (Porcine Acellular Dermal Matrix, PADM)
- Where
- 4 sites in France
- Volunteers
- 92 people
- Sponsor
- Meccellis Biotech
Intracranial Aneurysm
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial…
- Trial name
- SUNRISE (NCT00486226)
- Testing
- Vascular Reconstruction Device
- Where
- Belgium
- Volunteers
- 105 people
- Sponsor
- Codman & Shurtleff
Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
BIOCHROMADERM® PMCF STUDY
The goal of this observational study is to: To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation; To confirm the…
- Trial name
- NCT07261904
- Where
- 3 sites in France
- Volunteers
- 115 people
- Sponsor
- Laboratoires BIOTIC Phocea
Breast Cancer Female
Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other…
- Trial name
- SCderm (NCT06553859)
- Testing
- No intervention conducts.
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- DOF Inc.