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
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
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
Osteoarthritis, Knee
Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation
This investigation is intended to provide clinical information about alignment using TruMatch™ and to compare the results to a conventional total knee replacement.
- Trial name
- NCT01108237
- Testing
- TruMatch™ Personalized Solutions, Total Knee Arthroplasty with Conventional Instrumentation.
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- DePuy Orthopaedics
Osteoarthritis, Post-traumatic Arthritis
ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty
This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable…
- Trial name
- SOLO (NCT02574312)
- Testing
- ATTUNE TKA with ATTUNE RUI, ATTUNE TKA with ATTUNE SUI
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 88 people
- Sponsor
- DePuy Orthopaedics
Osteo Arthritis Knee, Osteoarthritis
Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty
The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual…
- Trial name
- NCT04730271
- Testing
- Total Knee Replacement
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- DePuy Orthopaedics
Spinal Diseases
Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries).
- Trial name
- NCT03015142
- Testing
- New image-guidance software
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Degenerative Arthritis of Knee
Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched…
- Trial name
- NCT01084772
- Testing
- VISIONAIRE Total Knee Arthroplasty, Standard Total Knee Arthroplasty
- Where
- 7 sites in United States, Australia
- Volunteers
- 134 people
- Sponsor
- Smith & Nephew, Inc.
Pulmonary Arterial Hypertension
Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension.
- Trial name
- NCT01841762
- Testing
- Macitentan
- Where
- 81 sites in United States
- Volunteers
- 284 people
- Sponsor
- Actelion
Skin Care
Study to Assess the Cosmetic Changes in the Facial Skin After Use of a Topical Retinoid Product in Participants With Moderate to Severe Photodamage
This study will assess the cosmetic changes of a cosmetic topical retinoid product in participants with moderate to severe photodamage utilizing non-invasive in vivo skin imaging instrumentation.
- Trial name
- NCT03302559
- Testing
- Retinol Complex 0.5, Facial cleanser, Moisturizing lotion
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Allergan
Arthroplasty, Replacement, Hip
Pelvic Alignment Level (PAL) Instrument Evaluation
The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL) instrument in achieving desired acetabular position, desired leg length and offset after Total Hip Replacement (THR) reconstruction.
- Trial name
- PAL (NCT01312428)
- Testing
- Pelvic Alignment Level (PAL) Instrument, No Pelvic Alignment Level (PAL) Instrument
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Stryker Orthopaedics
Staphylococcal Vaccine
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of…
- Trial name
- STRIVE (NCT02388165)
- Testing
- Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
- Where
- 301 sites in United States, Austria and 9 more
- Volunteers
- 3,450 people
- Sponsor
- Pfizer
Failed Back Surgery Syndrome, Pain
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed…
- Conditions
- Failed Back Surgery Syndrome, Pain, Back Pain
- Trial name
- Evidence (NCT01036529)
- Testing
- Precision Spinal Cord Stimulator, Back Surgery
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Osteoporosis
Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX
Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after several fractures.
- Trial name
- NCT01998737
- Where
- 6 sites in Finland
- Volunteers
- 1,011 people, healthy volunteers welcome
- Sponsor
- Bone Index Finland Ltd
Epicondylitis of the Elbow, Biceps Tendon Disorder
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow
The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the…
- Trial name
- NCT05519228
- Testing
- ToggleLoc 2.9 mm Soft Tissue System
- Where
- 2 sites in United States, Spain
- Volunteers
- 83 people
- Sponsor
- Zimmer Biomet
Bankart Lesions, SLAP Lesion
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder
The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the…
- Conditions
- Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction
- Trial name
- NCT05584553
- Testing
- ToggleLoc 2.9 mm soft tissue device, JuggerLoc soft tissue device
- Where
- 3 sites in United States, Spain
- Volunteers
- 214 people
- Sponsor
- Zimmer Biomet
Infertility
TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment
The main purpose of the study was to evaluate the overall clinical value of GERI+ as an integrated embryo culture and assessment system, providing an undisturbed culture environment, continuous monitoring of embryo development…
- Trial name
- TICON (NCT03164551)
- Testing
- GERI+ incubator, Conventional incubator
- Where
- 17 sites in Canada, Denmark and 5 more
- Volunteers
- 408 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Arterial and Midline Catheterization
Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement
The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures.
- Trial name
- NCT02584673
- Testing
- Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Clear Guide Medical
Femoral Shaft Fracture
TRIGEN SURESHOT™ Distal Targeting System Study
The objective of this study is to quantitate the amount of radiation both subjects and surgeons are exposed to during intramedullary nailing of the femur using the TRIGEN SURESHOT Distal Targeting System versus Standard nailing…
- Trial name
- Sureshot (NCT01327508)
- Testing
- TRIGEN SURESHOT Distal Targeting Instrumentation., Free-hand technique
- Where
- 7 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Smith & Nephew, Inc.
Rotator Cuff Injuries, Shoulder Pain
Anaverse™ Glenoid System and Its Instrumentation
The objectives of this study are to confirm safety, performance and clinical benefits of the Anaverse™ Glenoid System and its instrumentation by analysis of standard scoring systems, radiographs and adverse event records.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy, Arthroplasty Complications
- Trial name
- NCT05215600
- Testing
- Anaverse Shoulder System
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- Zimmer Biomet