Clinical trials: Safety and Performance
Facial Lipoatrophy, Morphological Asymmetry of the Face
Safety and Performance of Princess® VOLUME for the Treatment of Facial Lipoatrophy, Asymmetry or Scars
In this study, eligible patients with the medical indications (facial lipoatrophy, morphological asymmetry of the face, or debilitating scars) will be treated with Princess® VOLUME, and then will return for follow-up assessments…
- Conditions
- Facial Lipoatrophy, Morphological Asymmetry of the Face, Debilitating Scars
- Trial name
- FLASH2 (NCT03050749)
- Testing
- Princess® VOLUME
- Where
- 3 sites in Austria
- Volunteers
- 56 people
- Sponsor
- Croma-Pharma GmbH
Diabetes, Endocrine, Nutritional and Metabolic Diseases (E00-E89)
COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy
The purpose of this research study is to collect information about a new treatment for Type 2 Diabetes Mellitus (T2DM), using a medical device called the Metabolic Neuromodulation System which is intended to help regulate blood…
- Trial name
- NCT02278068
- Testing
- Metabolic Neuromodulation System (MNS)
- Where
- 6 sites in New Zealand
- Volunteers
- 46 people
- Sponsor
- Metavention
Aortic Stenosis
Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a Transcatheter Aortic Valve replacement…
- Trial name
- NCT05866640
- Testing
- F2 filter and delivery system
- Where
- Georgia
- Volunteers
- 31 people
- Sponsor
- EnCompass Technologies, Inc.
Rotator Cuff Injuries
Performance and Safety of the FIXIT® Anchor in Arthroscopic Rotator Cuff Repair
Verification of the performance and safety of the first row resorbable threaded anchor FIXIT® in arthroscopic rotator cuff repair Non-interventional, prospective, non-comparative, multi-center study as part of the post-marketing…
- Trial name
- FIXIT®2018 (NCT05720286)
- Testing
- Arthroscopic rotator cuff repair
- Where
- 2 sites in France
- Volunteers
- 30 people
- Sponsor
- Science and biomaterials
Mandibular Fractures, Mandible Fracture
Facial iD Customized Mandible Reconstruction Plates
A retrospective post market follow up to confirm the safety and performance of Stryker's Customized Plates for Mandibular Reconstruction.
- Conditions
- Mandibular Fractures, Mandible Fracture, Mandible; Deformity, MANDIBLE
- Trial name
- NCT07245758
- Testing
- Mandibular reconstruction
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Stryker Craniomaxillofacial
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
Muscle Performance, Sarcopenic Obesity
Safety and Efficacy of IMM01-STEM Against Placebo on Muscle Performance in Seniors With Obesity and Muscle Weakness
Placebo controlled study for safety and efficacy of IMM01-STEM on muscle performance in seniors with obesity and muscle weakness
- Trial name
- NCT06600581
- Testing
- IMM01-STEM
- Where
- 4 sites in United States
- Volunteers
- 55 people
- Sponsor
- Immunis, Inc.
Cardiac Arrhythmia
The Objective of This Multicentre Study is to Collect Operative Data on the Related Clinical Functional Outcomes and Complications and of Market Approved Alcis Electrophysiology Catheters to Demonstrate Safety and Performance of These Devices in a Real-world Setting
The objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved Alcis electrophysiology catheters to demonstrate safety and performance of…
- Trial name
- NCT05314218
- Testing
- Electrophysiology catheters and cables
- Where
- 2 sites in France
- Volunteers
- 168 people
- Sponsor
- Alcis
Pancreatic Cancer Non-resectable
Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer
This study is testing a new way to deliver the chemotherapy drug Gemcitabine in pancreatic tumors using the catheter Extroducer® Infusion Catheter System.
- Trial name
- NCT07575191
- Testing
- Gemcitabine, Extroducer Infusion Catheter System
- Where
- Sweden
- Volunteers
- 9 people
- Sponsor
- Smartwise Sweden AB
Glaucoma
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg…
- Trial name
- NCT00772330
- Testing
- Glaucoma Drainage Device
- Where
- Dominican Republic
- Volunteers
- 23 people
- Sponsor
- InnFocus Inc.
Cochlear Implants
Investigating the Performance and Safety of the AudioKey 3, a Device That Provides Remote Control Options and Status Information for Compatible MED-EL Audio Processors, by Analyzing Data Logged by the App and Responses to a User Survey
Investigating the performance and safety of the AudioKey 3, a device that provides remote control options and status information for compatible MED-EL audio processors, by analyzing data logged by the app and responses to a user…
- Trial name
- NCT06817928
- Where
- Austria
- Volunteers
- 46 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Rectal Prolapse
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in…
- Trial name
- NCT04130555
- Testing
- CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)
- Where
- 3 sites in France
- Volunteers
- 55 people
- Sponsor
- Meccellis Biotech
Marginal Bone Level Change
A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components
This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30…
- Trial name
- NCT04737421
- Testing
- NobelActive TiUltra implant, NobelParallel CC TiUltra implants, NobelReplace CC TiUltra implants
- Where
- 32 sites in United States, Australia and 12 more
- Volunteers
- 1,000 people
- Sponsor
- Nobel Biocare
Correction of Facial Wrinkles/Folds, Facial Volume Enhancement
Post-Market Clinical Follow-up Performance and Safety Study of Etermis 3 and 4 in the Face
To confirm the clinical performance of Etermis 3 and Etermis 4 based on the blinded investigator´s assessments on the respective Merz Aesthetics Scales from day 0 (D0) pre-injection to month 6/7 (depending on touch up) visit for…
- Trial name
- POMET (NCT04210258)
- Testing
- Etermis 3, Etermis 4
- Where
- 6 sites in Germany
- Volunteers
- 154 people
- Sponsor
- Merz Pharmaceuticals GmbH
Pregnancy
Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
- Trial name
- NCT03504189
- Testing
- PregSense™, Cardiotocopraphy (CTG)
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 151 people
- Sponsor
- Nuvo-Group, Ltd.
Xerostomia
Evaluation of an Electro-stimulator for the Treatment of Xerostomia
This is a multinational trial, aimed at testing the safety and performance of a electrostimulating device ("GenNarino") to treat dry mouth, over one year.
- Trial name
- GenNarino (NCT00509808)
- Testing
- Electrostimulation
- Where
- Finland
- Volunteers
- 200 people
- Sponsor
- Saliwell Ltd.
Aortic Stenosis
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.
- Trial name
- SOURCE 3 (NCT02698956)
- Testing
- TAVI (Transcatheter Aortic Valve Implantation)
- Where
- 73 sites in Denmark, Finland and 8 more
- Volunteers
- 2,000 people
- Sponsor
- Edwards Lifesciences
Bone Defects, Orthopaedic Surgery (30 Minutes or Longer)
Evaluation of the Safety and Performance of the Neocement® Inject P
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® Inject P when used according to its intended purpose and current clinical applications.
- Trial name
- NCT06973239
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Bioceramed
Bone Defects
Retrospective Collection of Safety and Performance Data
This is a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects…
- Trial name
- NCT04644536
- Testing
- Bone graft substitute
- Where
- Portugal
- Volunteers
- 50 people
- Sponsor
- Bioceramed
Aphakia, Corneal Astigmatism
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
The purpose of this study was to evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) in subjects with pre-existing corneal astigmatism in need of cataract surgery.
- Conditions
- Aphakia, Corneal Astigmatism, Cataract
- Trial name
- NCT03050697
- Testing
- HARMONI® Modular Toric Intraocular Lens, Cataract extraction with intraocular lens (IOL) implantation
- Where
- New Zealand
- Volunteers
- 16 people
- Sponsor
- ClarVista Medical
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