Clinical trials: Instrumentation
Patient-Reported Outcomes (PRO)
Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument
The purpose of this study is to conduct concept elicitation and cognitive debriefing interviews with patients who have been implanted with the KAMRA inlay in order to assess the content validity of a PRO instrument
- Trial name
- NCT03536715
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- AcuFocus, Inc.
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
Degenerative Disc Disease (DDD), Spinal Stenosis
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems…
- Conditions
- Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities
- Trial name
- INFO SPINE (NCT07615491)
- Testing
- Titania® Cervical Interbody Fusion Cage (Titanium), Titania® Cervical Interbody Fusion Cage (PEEK), Titania® Posterior Cervical Stabilization System
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 561 people
- Sponsor
- Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.
Corneal Transplantation
Corneal Endothelium Delivery Instrument
The purpose of this study is to determine whether the surgical outcomes in patients undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of an insertion device over the traditional forceps…
- Trial name
- NCT00874835
- Testing
- EndoSaver™ Corneal Endothelium Delivery Instrument
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Ocular Systems, Inc.
Primary Open Angle Glaucoma (POAG)
A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
This study enrolls adults with primary open angle glaucoma (POAG) who underwent goniotomy intraocular pressure (IOP)-lowering surgery with the C-Rex Instrument.
- Trial name
- CIRCLE (NCT06615661)
- Testing
- C-Rex Instrument
- Where
- 6 sites in United States
- Volunteers
- 100 people
- Sponsor
- Iantrek, Inc.
Hip Arthritis, Hip Disease
MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II…
- Conditions
- Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries
- Trial name
- NCT05199870
- Testing
- RingLoc Bipolar Acetabular Cup, Endo II Femoral Head
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Zimmer Biomet
Diabetes
Study of the Analytical Performance of ALLEGRO™ Instrument
A new analyser has been developed (Allegro™) which allows the tests to be undertaken at the clinic, with the results available in a few minutes.
- Trial name
- NCT04035044
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Nova Biomedical
Glaucoma
Instrument for Glaucoma Early Detection and Monitoring
To introduce a rapid and objective electrophysiological technique that can assess visual function in the magnocellular pathway, which is thought to be affected in early-stage glaucoma.
- Trial name
- IGDM (NCT00578110)
- Testing
- Glaucoma Diagnosis, Name: Neucodia
- Where
- 5 sites in United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Synabridge Corporation
G6PD, G6PD Deficiency
Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates
A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.
- Trial name
- NCT04146246
- Testing
- G6PD assay
- Where
- 3 sites in United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Baebies, Inc.
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
Hemodialysis
Ultrasound Instrument to Prevent Dialysis Graft Failure
This research study aims to show that a newly developed investigational Doppler instrument can reliably measure blood flow in dialysis access grafts, to see if a decrease in the flow may be a sign of impending graft failure and…
- Trial name
- NCT00309348
- Testing
- Weekly measurement of graft flow
- Where
- 2 sites in United States
- Volunteers
- 111 people
- Sponsor
- DVX, LLC
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
Anemia
A Clinical Evaluation of the OrSense Non-invasive Blood Hb/Hct Measurement Instrument, the Hemo-Monitor NBM200/MP
The purpose of the study is to define the precision, accuracy and variability of the NBM-200 system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood analyzer by comparing two consecutive Hb…
- Trial name
- NCT01915953
- Where
- Israel
- Volunteers
- 500 people
- Sponsor
- OrSense, Ltd.
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
Hip Osteoarthritis, Hip Disease
MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants…
- Conditions
- Hip Osteoarthritis, Hip Disease, Hip Fractures, Hip Injuries
- Trial name
- NCT04093739
- Testing
- G7 Freedom Constrained Liners
- Sponsor
- Zimmer Biomet
Hemorrhoids
Prevention and/or Reduction of Hemorrhoids and/or Thrombosed External Hemorrhoids Using the HEM-AVERT Perianal Stabilizer Instrument
This study is being conducted to evaluate an investigational instrument called the HEM-AVERT Perianal Stabilizer and its efficacy in reducing the occurrence or severity of hemorrhoids and thrombosed external hemorrhoids (TEH)…
- Trial name
- HEM-AVERT (NCT00487045)
- Testing
- Hem-Avert Perianal Stabilizer
- Where
- 3 sites in United States
- Volunteers
- 176 people
- Sponsor
- Stetrix, Inc.
Gynecologic Surgery
Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy
The study is designed to evaluate the safety of performing in-bag morcellation of uterus tissues during laparoscopic hysterectomy (LSH or TLH).
- Trial name
- NCT03216772
- Testing
- Olympus PK Morcellator in PneumoLiner
- Sponsor
- Olympus Surgical Technologies Europe
Acquired Immunodeficiency Syndrome
Accuracy Evaluation of the BD FACS Presto System
The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune status of patients with, or suspected of developing, immune deficiencies such as AIDS.
- Trial name
- NCT02396355
- Testing
- Investigational BD FACSPresto System, BD FACSCalibur flow cytometer, Sysmex hematology analyzer KX-21
- Where
- 6 sites in United States, India and 2 more
- Volunteers
- 583 people
- Sponsor
- Becton, Dickinson and Company