Clinical trials: Surgical Performance
Primary Arthritis, Secondary Arthritis
A Multi-centre Study to Assess the Long-term Performance of the Silent Hip™ in Primary Total Hip Replacement Surgery
The purpose of this study is to monitor the performance and of the Silent Hip™ in the treatment of patients with hip joint disease requiring a total hip replacement.
- Trial name
- NCT01383824
- Testing
- Silent™ Hip
- Where
- 9 sites in Denmark, Germany and 3 more
- Volunteers
- 89 people
- Sponsor
- DePuy International
Open Angle Glaucoma (OAG)
Safety and Performance Study of the CyPass System Applier Model 241
This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used…
- Trial name
- RePASS (NCT02228577)
- Where
- Germany
- Volunteers
- 172 people
- Sponsor
- Transcend Medical, Inc.
Bone Defects, Orthopaedic Surgery (30 Minutes or Longer)
Evaluation of the Safety and Performance of the Neocement®
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® when used according to its intended purpose and current clinical applications.
- Trial name
- Neocement01 (NCT06973226)
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Bioceramed
Breast Cancer Female
A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure.
- Trial name
- NCT03300206
- Testing
- Breast Biopsy
- Where
- 7 sites in United States
- Volunteers
- 525 people
- Sponsor
- Hologic, Inc.
Breast Surgery, Lymph Node Excision
Safety & Performance of CANOpus PINtuition Surgical Marker Navigation
The goal of this clinical trial is to evaluate the safety and performance of the Canopus Marker in adult breast cancer patients who are scheduled for breast-conserving surgery. The main questions it aims to answer are: 1.
- Trial name
- CANOPIN (NCT06950021)
- Testing
- Magnetic seed
- Where
- Netherlands
- Volunteers
- 35 people
- Sponsor
- Sirius Medical Systems B.V.
Cerebrospinal Fluid Leakage
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.
- Trial name
- NCT01295619
- Testing
- I-020805
- Where
- 4 sites in Germany, Hungary
- Volunteers
- 41 people
- Sponsor
- Kuros Biosurgery AG
Aphakia, Astigmatism
Evaluation of Long-term Safety and Performance of PanOptix Trifocal Intraocular Lens (IOL)
The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term safety and performance of the AcrySof IQ PanOptix IOL toric and non-toric models in subjects bilaterally implanted with these IOLs for 3…
- Conditions
- Aphakia, Astigmatism, Presbyopia
- Trial name
- NCT06166901
- Testing
- AcrySof IQ PanOptix IOL Toric, AcrySof IQ PanOptix IOL Non-Toric
- Where
- 7 sites in Spain
- Volunteers
- 211 people
- Sponsor
- Alcon Research
Surgery, Central Line Associated Blood Stream Infections (CLABSI)
BIP CVC Clinical Safety and Performance Study
The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and performance and compare it to corresponding standard uncoated CVC.
- Trial name
- NCT02811380
- Testing
- BIP CVC, Uncoated Standard CVC
- Where
- Sweden
- Volunteers
- 36 people
- Sponsor
- Bactiguard AB
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
Wound Heal
Performance, Safety and Efficacy of PICO Device.
The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the…
- Trial name
- NCT03698968
- Testing
- Negative Pressure Wound Therapy
- Where
- 11 sites in Switzerland, United Kingdom
- Volunteers
- 50 people
- Sponsor
- Smith & Nephew, Inc.
Spinal Surgery
Study Assessing Safety and Performance of OrtoWell Distractor in Patients Undergoing Spinal Surgery
Study to Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing Spinal Surgery
- Trial name
- NCT03501810
- Testing
- Distractor use for vertebrae separation
- Where
- Germany
- Volunteers
- 32 people
- Sponsor
- OrtoWay AB
Sleep Apnea, Hypertension
Tri Staple Technology Stapler Used in Gastric Bypass
The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
- Conditions
- Sleep Apnea, Hypertension, Hyperlipidemia, Coronary Artery Disease
- Trial name
- NCT01026103
- Testing
- Tri Staple Technology stapler
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Colorectal Surgery
Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or…
- Trial name
- NCT03423485
- Testing
- CG-100 Intraluminal Bypass Device
- Where
- 5 sites in France, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- Colospan Ltd.
AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation
- Trial name
- VITTA (NCT06959836)
- Testing
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Where
- 3 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Cardiac Disease, Myocardial Dysfunction
Temporary Epicardial Pace Wire With Integrated Sensor for Continuous Postoperative Monitoring of Myocardial Function
Transesophageal echocardiography is used to monitor cardiac wall motion at various time points during open-heart surgery. After surgery, the measurements are made at various time points by transthoracic echocardiography.
- Trial name
- NCT04886934
- Testing
- CS1 System
- Where
- Norway
- Volunteers
- 38 people
- Sponsor
- Cardiaccs AS
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.
Transcatheter Aortic Valve Implantation
Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System. The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months.
- Trial name
- EMPIRE-II (NCT05804903)
- Testing
- (ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 7 sites in Finland, Germany and 3 more
- Volunteers
- 177 people
- Sponsor
- NVT GmbH
Glaucoma, Open Angle Glaucoma
Performance and Safety of the ARGOS-SC Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery
The purpose of this study is to evaluate both the safety and feasibility of the surgical implantation of the ARGOS-SC implant during non-penetrating glaucoma surgery and the safety and usability of the ARGOS-SC implant and system…
- Trial name
- ARGOS-SC01 (NCT03756662)
- Testing
- ARGOS-SC suprachoroidal pressure sensor
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Implandata Ophthalmic Products GmbH
Fractures, Bone, Impending Fracture
Retrospective Study on Clinical Performance and Safety Profile of Agile Nail
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the Agile intramedullary nail, used in pediatric patients according to the manufacturer Instructions For…
- Conditions
- Fractures, Bone, Impending Fracture, Deformity; Bone
- Trial name
- Agile (NCT06412939)
- Testing
- Agile Nail
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Orthofix s.r.l.
Gastrointestinal Cancer
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD
The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.
- Trial name
- NCT06588881
- Testing
- nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection
- Where
- Italy
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GEM SRL