Clinical trials: Safety and Performance
Knee Osteoarthritis
A Study to Evaluate the Clinical Performance and Safety of an Intra-articular Hyaluronic Acid in Knee Osteoarthritis
This is a study to evaluate the Clinical Performance and Safety of a single intra-articular (i.a.) injection of hyaluronic acid product (as HL-01) in the treatment of pain due to osteoarthritis (OA) of the knee.
- Trial name
- NCT03200288
- Testing
- HL-01: high and low molecular weight hyaluronic acid
- Where
- 31 sites in Belgium, Germany and 3 more
- Volunteers
- 692 people
- Sponsor
- IBSA Institut Biochimique SA
Full Thickness Rotator Cuff Tear
Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears.
- Trial name
- NCT01256242
- Testing
- Augment Rotator Cuff, Standard Suture Repair
- Where
- 4 sites in Canada
- Volunteers
- 31 people
- Sponsor
- BioMimetic Therapeutics
Obesity
Safety and Performance of the CAVU Medical, Inc. Attune Tubing Study
The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.
- Trial name
- NCT01422941
- Testing
- CAVU Attune Device
- Where
- 2 sites in Australia
- Volunteers
- 40 people
- Sponsor
- Cavu Medical, Inc.
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
Pacemaker, Bradycardia
Adapta Pacing System Clinical Study
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow).
- Trial name
- NCT00307073
- Testing
- Implantable Pulse Generator
- Where
- 7 sites in Austria, Czechia and 4 more
- Volunteers
- 120 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Glaucoma
Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with…
- Trial name
- NCT03868254
- Testing
- XEN Group, Phacoemulsification
- Where
- United States
- Volunteers
- 174 people
- Sponsor
- Allergan
Acne, Scars
Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.
The scope of this open label clinical trial is to evaluate and confirm the performance of Papix acne scar in the prevention and improvement of acne scars in subject suffering for mild to moderate acne.
- Trial name
- NCT04806594
- Testing
- Papix acne scar
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Relife S.r.l.
Ischemic Heart Disease
Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Stents in Routine Practice
The goal of this observational study is to collect safety and performance information in the setting of a large-scale clinical registry.
- Trial name
- e-Yukon (NCT05703646)
- Where
- United Arab Emirates
- Volunteers
- 5,000 people
- Sponsor
- Translumina GmbH
Postpartum Hemorrhage
Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage
This is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade treatment for uterine postpartum hemorrhage…
- Trial name
- NCT06033170
- Testing
- CELOX™ PPH
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Medtrade
Type 2 Diabetes Mellitus
A Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).
- Trial name
- NCT02419859
- Testing
- PaQ® Insulin Delivery Device, Insulin, Asp(B28)-
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- CeQur Corporation
Degenerative Mitral Regurgitation
FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation.
- Trial name
- NCT07470788
- Testing
- Transcatheter Mitral Valve Repair
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Vesalius Cardiovascular Inc.
Cataract Senile
Study to Confirm Safety and Performance of a New Multifocal IOL
Prospective, non-comparative, multicenter study on medical device with 12 months follow-up.
- Trial name
- NCT06247683
- Testing
- trifocal intraocular lens
- Where
- 11 sites in Czechia, Germany and 1 more
- Volunteers
- 135 people
- Sponsor
- Carl Zeiss Meditec AG
Sjogren Syndrome
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Treatment Method for Sjogren's Syndrome (SS)
The purpose of the study is to investigate the effect and safety of the Walther System delivering INMEST (intranasal mechanical stimulation) on people with Sjogren\'s syndrome.
- Trial name
- A-SS-001 (NCT06626477)
- Testing
- Intra nasal mechanical stimulation treatment (INMEST)
- Where
- Sweden
- Volunteers
- 26 people
- Sponsor
- Abilion Medical Systems AB
Multiple Sclerosis
Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting
The primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting.
- Trial name
- NCT06261541
- Testing
- ABLE Exoskeleton
- Where
- Spain
- Volunteers
- 33 people
- Sponsor
- ABLE Human Motion S.L.
Shoulder Pain, Shoulder Injuries
MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere
The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary…
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Arthritis
- Trial name
- NCT04003272
- Testing
- Comprehensive Reverse Versa-Dial Titanium Glenosphere
- Where
- 2 sites in United States
- Volunteers
- 59 people
- Sponsor
- Zimmer Biomet
Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic
Cemented TrendHip® - Multicenter PMCF Study on Total Indications
This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational…
- Conditions
- Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic, Necrosis, Femur Head, Rheumatoid Arthritis
- Trial name
- TRESTI (NCT04943328)
- Testing
- Total Hip Arthroplasty
- Where
- 4 sites in Germany
- Volunteers
- 119 people
- Sponsor
- Aesculap AG
Journey II CR Total Knee System
Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS)
The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.
- Trial name
- JIICR (NCT03885531)
- Testing
- Total knee arthroplasty with Journey II CR Total Knee System
- Where
- 6 sites in United States
- Volunteers
- 586 people
- Sponsor
- Smith & Nephew, Inc.
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
Lipolysis
RF and PEMF Following Liposuction
The Venus Legacy LB2 Body applicator is intended for circumference reduction treatment by reducing fat cell size and enhancing collagen synthesis as the result of thermal and non-thermal collagen stimulation.
- Trial name
- NCT03588702
- Testing
- RF and PEMF treatment
- Where
- Spain
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Venus Concept
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
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