Clinical trials: Surgical Performance, open to volunteers
- Condition Surgical Performance
- Status Open to volunteers
- Funder type Industry (pharma, biotech, devices)
Off Pump Coronary Artery Bypass Surgery
Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
This observational study aims to collect data on the performance and safety of Getinge's Beating Heart products used during open-heart coronary artery bypass graft surgery.
- Trial name
- NCT07286890
- Testing
- Vacuum Stabilizer System, Vacuum Positioner System, Blower/Mister
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Maquet Cardiovascular
Sport Surgery
Sport Surgery Products Outcomes - A Post-market Follow-up
Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products.
- Trial name
- NCT06532929
- Testing
- Orthopaedic surgeries (ankle), Orthopaedic surgeries (shoulder), Orthopaedic surgeries (knee)
- Where
- 10 sites in France
- Volunteers
- 390 people
- Sponsor
- Teknimed
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Arterial Thromboembolism
A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter
A post market clinical study to confirm the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on patients undergoing surgical treatment for the removal of arterial emboli and/or thrombi
- Trial name
- SLC (NCT05386277)
- Testing
- TufTex Single Lumen Embolectomy Catheter
- Where
- 3 sites in Belgium, Germany and 1 more
- Volunteers
- 112 people
- Sponsor
- LeMaitre Vascular
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
- Trial name
- IMED-GLOW400 (NCT07366892)
- Testing
- GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 37 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Hip Osteoarthritis, Rheumatoid Arthritis
G7 Dual Mobility With Vivacit-E or Longevity PMCF
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of…
- Conditions
- Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis
- Trial name
- NCT05548972
- Testing
- G7 Dual Mobility with Vivacit-E bearing, G7 Dual Mobility Longevity bearing
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 358 people
- Sponsor
- Zimmer Biomet
Thrombus, Embolus
A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters
A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter
- Conditions
- Thrombus, Embolus, Occlusion; Vessel
- Trial name
- OTW (NCT05386342)
- Testing
- TufTex Over-the-Wire Embolectomy Catheter
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 112 people
- Sponsor
- LeMaitre Vascular
Robotic-assisted Soft-tissue Surgery
Versius Robotic Surgery in the NHS: A Multi-Specialty Retrospective Study
To generate robust, real-world comparative evidence on the short and long-term clinical outcomes following surgical intervention with Versius Robot-Assisted Surgery versus surgical standard of care across predefined soft-tissue…
- Trial name
- NCT07761299
- Where
- 5 sites in United Kingdom
- Volunteers
- 1,200 people
- Sponsor
- CMR Surgical Ltd
Osteoarthritis, Knee, Joint Diseases
Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
Randomized, controlled, single center observational study to compare the safety and performance of navigation-assisted OrthoPilot Elite and robotic-assisted MAKO total knee arthroplasty (TKA).
- Conditions
- Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy
- Trial name
- ORMAK (NCT05980442)
- Testing
- Navigated total knee arthroplasty, Robot assisted total knee arthroplasty
- Where
- Germany
- Volunteers
- 140 people
- Sponsor
- Aesculap AG
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.
- Trial name
- NCT07379112
- Testing
- Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
- Volunteers
- 500 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Cardiac Surgery, Heart Surgery
Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety.
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery
- Trial name
- NCT07354841
- Testing
- Eurosets Venous and Arterial Cannula, Control Arterial and Venous Cannulas
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Eurosets S.r.l.
Bone Augmentation
Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neobone® when used according to its intended purpose and current clinical applications.
- Trial name
- NeoDent01 (NCT07179497)
- Where
- Portugal
- Volunteers
- 66 people
- Sponsor
- Bioceramed
Degenerative Disc Disease, Craniocervical Injuries
Posterior Cervical Fixation Study
The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported…
- Conditions
- Degenerative Disc Disease, Craniocervical Injuries, Cervical Radiculopathy, Cervical Disc Disease
- Trial name
- NCT04770571
- Testing
- observational study
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- NuVasive
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.
Vertebral Fracture, Compression Fracture
Spine Bone Cements Outcomes - Post Market Follow-up
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all…
- Conditions
- Vertebral Fracture, Compression Fracture, Osteoporotic Fractures
- Trial name
- NCT06367582
- Testing
- Vertebroplasty (VP), Kyphoplasty (KP), Pedicular Screw Augmentation (PSA)
- Where
- 12 sites in France, Portugal and 2 more
- Volunteers
- 500 people
- Sponsor
- Teknimed
Atrial Appendage
CLAARITY is a Prospective, Observational, Single-arm, Multi-center, Post-market US Study Designed to Evaluate the Safety and Performance of the ECLIPTIS Left Atrial Appendage Exclusion System for Exclusion of the Left Atrial Appendage (LAA) During Concomitant Open-heart Cardiac Surgery.
CLAARITY is a prospective, observational, single-arm, multi-center, post-market US study designed to evaluate the safety and performance of the ECLIPTIS clip in a minimum of 168 participants.
- Trial name
- CLAARITY (NCT07742839)
- Testing
- Edwards ECLIPTIS Left Atrial Appendage Exclusion System
- Volunteers
- 168 people
- Sponsor
- Edwards Lifesciences
Pelvic Organ Prolapse (POP), Genital Prolapse
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
- Conditions
- Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse, Laparoscopic Surgery
- Trial name
- NCT07066761
- Testing
- Laparoscopic lateral suspension with surgical mesh (LatGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 85 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Chronic Low-back Pain, Herniated Disc
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV…
- Conditions
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis
- Trial name
- LISA-PMCF (NCT04631133)
- Testing
- Lumbar Implant for Stiffness Augmentation (LISA)
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 136 people
- Sponsor
- BACKBONE
Cervical Spondylosis, Cervical Radiculopathy
NuVasive® ACP System Study
The primary objective of this study is to evaluate the safety and performance of anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System as measured by reported complications, radiographic…
- Conditions
- Cervical Spondylosis, Cervical Radiculopathy, Cervical Myelopathy, Cervical Disc Disease
- Trial name
- NCT05066711
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- NuVasive
Spine Surgery
An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
The purpose of this research study is to: test the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of…
- Trial name
- NCT06827795
- Testing
- A burr used in spine surgery
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Surgify Medical Oy