Clinical trials: Instrumentation
Pulmonary Arterial Hypertension
A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain
Prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study. Primary objectives: To evaluate the psychometric characteristics of reliability and construct validity of the French, Italian and Spanish…
- Trial name
- ORCHESTRA (NCT02081690)
- Testing
- Macitentan
- Where
- 39 sites in France, Italy and 1 more
- Volunteers
- 160 people
- Sponsor
- Actelion
Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease
PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella
The study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study.
- Conditions
- Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease, Functional Deformity, Revision Total Knee Arthroplasty
- Trial name
- NCT05253976
- Where
- Switzerland
- Sponsor
- Zimmer Biomet
Hydrocephalus
Guided Application of Ventricular Catheters
Failure of ventricular catheters remains a significant problem in patients with hydrocephalus. The purpose of this study is to determine whether the use of a simple instrument assisted by a smart phone application software can…
- Trial name
- GAVCA (NCT01811589)
- Testing
- Thomale-Guide, Free-hand
- Where
- 9 sites in Germany
- Volunteers
- 144 people
- Sponsor
- Aesculap AG
Sunscreen
A Study to Evaluate the Whitening Effect of Mineral Sunscreens in Multi-Cultural Skin Tones
The purpose of this study is to evaluate the whitening potential effect of different mineral sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment and also evaluate the relationship…
- Trial name
- NCT05565625
- Testing
- Sunscreen A, Sunscreen B, Sunscreen C
- Where
- United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
Femur Fracture, Osteotomy
ZNN Bactiguard Antegrade Femoral Nails PMCF Study
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical…
- Trial name
- NCT05339360
- Testing
- Femoral fixation with intramedullary nails
- Where
- 2 sites in Spain, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract
Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument
Clinical evaluation of the safety and performance of microwave coagulation using the HS1 Instrument for actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract
- Trial name
- NCT04406116
- Testing
- Microwave coagulation using HS1 Instrument
- Where
- United Kingdom
- Volunteers
- 35 people
- Sponsor
- Creo Medical Limited
Elbow Injury
MDR ExploR Radial Head System PMCF
The objective of this retrospective and prospective consecutive series PMCF study is to collect long-term data confirming safety, performance and clinical benefits of the ExploR Radial Head System (implants and instrumentation)…
- Trial name
- NCT05583448
- Testing
- ExploR Radial Head
- Where
- 2 sites in United States, Norway
- Volunteers
- 93 people
- Sponsor
- Zimmer Biomet
Hearing Loss
Evaluation of Investigational Hearing Instrument Features
The goal of this clinical trial is to learn how hearing instruments perform in varying environmental settings in adults with hearing loss.
- Trial name
- NCT06710236
- Testing
- Hearing instrument
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Sonova AG
Technology, Comparison
Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty
The primary objective of this study is to examine the optimization of Reverse Shouder Arthroplasty implant position between GPS and conventional techniques.
- Trial name
- NCT05615259
- Where
- 2 sites in Netherlands
- Volunteers
- 260 people
- Sponsor
- Exactech
Degenerative Disc Disease, Spondylolisthesis
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00549913
- Testing
- NeoFuse, posterolateral spinal fusion with instrumentation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mesoblast, Ltd.
Revision of a Shoulder Prosthesis
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System
The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study.
- Trial name
- NCT05358574
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Zimmer Biomet
Proximal Humeral Fracture, Proximal Tibia Fractures
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
The study is a monocentric, retro- and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Zimmer® Plates…
- Conditions
- Proximal Humeral Fracture, Proximal Tibia Fractures, Diaphyseal Fracture
- Trial name
- NCT05215613
- Where
- Italy
- Volunteers
- 57 people
- Sponsor
- Zimmer Biomet
Blindness, Acquired
A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals
This study aims to validate an observer-rated assessment titled "Functional Low-Vision Observer Rated Assessment (FLORA-20)", which comprises 20 functional vision tasks commonly performed in or around a blind individual's home…
- Trial name
- FLORA-20 (NCT04312763)
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Second Sight Medical Products
Osteotomy, Trochanteric Fractures
ZNN Bactiguard Cephalomedullary Nails PMCF Study
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Cephalomedullary Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit…
- Conditions
- Osteotomy, Trochanteric Fractures, Sub-trochanteric Fractures, Femoral Shaft Fracture
- Trial name
- NCT05362864
- Testing
- Fracture fixation via Intramedullary Nailing
- Where
- 3 sites in France, Spain
- Volunteers
- 149 people
- Sponsor
- Zimmer Biomet
Osteoarthritis of the Knee
VISIONAIRE™ Value Study
This is a single center randomized observational study that evaluates the cost benefit ratio between the use of two types of instrumentation in TKA: standard instrumentation vs. VISIONAIRE™ Patient Matched Technology.
- Trial name
- NCT01107769
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Smith & Nephew, Inc.
Periorbital Hyperpigmentation
Physiopathologic Aspects and Quality of Life in Participants With Eye Dark Circles
This study will evaluate the physiopathologic characteristics of dark circles in participants with various ethnicities and Fitzpatrick Skin Types and the impact of the dark circles on the quality of life.
- Trial name
- NCT03400202
- Testing
- Skin imaging, Facial cleanser
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Allergan
Fractures, Bone, Fracture Multiple
MDR - Biomet Cannulated Screws
The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when…
- Trial name
- NCT04002518
- Testing
- Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.
- Where
- 3 sites in United States
- Volunteers
- 51 people
- Sponsor
- Zimmer Biomet
Atrial Fibrillation
Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue near the PV.
- Trial name
- CAI (NCT02770989)
- Testing
- Vimecon Laser CAI percutaneous cardiac ablation
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 1 people
- Sponsor
- Vimecon GmbH
Pathology
Instrument Precision Study for Validation of Philips Dx
The objective of this study is to evaluate precision of the Philips Dx system.
- Trial name
- NCT02699970
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Severe Knee Pain, Severe Knee Disability
Persona Revision Knee System EMEA PMCF Study
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.
- Conditions
- Severe Knee Pain, Severe Knee Disability, Revision Arthroplasty
- Trial name
- NCT07843966
- Where
- 2 sites in Denmark, Spain
- Volunteers
- 238 people
- Sponsor
- Zimmer, GmbH