Clinical trials: Instrumentation
Leukemia, Myelogenous, Chronic
Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML)
The objective of this study is to establish the performance of an assay that detects mRNA transcript levels in patients diagnosed with CML. The study is conducted at locations within the United States.
- Trial name
- NCT03421626
- Testing
- Xpert BCR-ABL Ultra
- Where
- 7 sites in United States
- Volunteers
- 266 people
- Sponsor
- Cepheid
Arthritis, Osteoarthritis
A Comparison of Patients Receiving a Unicompartmental Knee Replacement With Robotic Assistance or With Conventional Instrumentation
A unicompartmental (partial) knee replacement (UKR) is the removal of one part of the knee joint (a condyle), that has become damaged due to osteoarthritis, and replacing it with an artificial implant.
- Conditions
- Arthritis, Osteoarthritis, Knee, Joint Diseases
- Trial name
- NCT04992078
- Testing
- NAVIO/CORI Surgical System, Non-robotic conventional instrumentation
- Where
- 6 sites in Ireland, United Kingdom
- Sponsor
- Smith & Nephew Orthopaedics AG
Healthy Volunteers, Syphilis Serologic Assay Development
Blood Donation Study for ALPCO Syphilis-T and Syphilis-NT Assay Development
This prospective, single-center study will collect blood from approximately 50 adult volunteers aged 22 years or older. Participants will provide informed consent, complete an eligibility review, and undergo one blood draw of…
- Conditions
- Healthy Volunteers, Syphilis Serologic Assay Development, Blood Specimen Collection, Diagnostic Assay Development
- Trial name
- NCT07830550
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Knee Pain Chronic, Osteoarthritis
Persona Ti-Nidium Post-Market Clinical Follow-up
The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
- Conditions
- Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Trial name
- TKA (NCT04817969)
- Testing
- Zimmer Biomet Persona Ti-Nidium Total Knee System
- Where
- 7 sites in United States
- Volunteers
- 240 people
- Sponsor
- Zimmer Biomet
Anterior Cruciate Ligament Injury, Rotator Cuff Tear
MDR EZ Pass and Precision Flexible Reamer
The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
- Trial name
- NCT03914703
- Testing
- EZ Pass Suture Passer
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Zimmer Biomet
Pulmonary Arterial Hypertension
Patient Reported Outcomes in Pulmonary Arterial Hypertension
Develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.
- Trial name
- PROPAH (NCT01792622)
- Testing
- Interview, Questionnaire
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
Acromegaly
Validation Study of the SAGIT® Instrument in Acromegaly
Patients will be treated in accordance with the standard medical practice of the hospital where they have been recruited during their participation in this study. No additional assessments or tests will be required.
- Trial name
- SAGIT (NCT02539927)
- Where
- 33 sites in United States, Belgium and 8 more
- Volunteers
- 227 people
- Sponsor
- Ipsen
Disorder of Middle Ear, Otosclerosis of Middle Ear
Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively
Feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (PalpEar).
- Conditions
- Disorder of Middle Ear, Otosclerosis of Middle Ear, Cholesteatoma, Middle Ear
- Trial name
- PalpEar (NCT02554422)
- Testing
- PalpEar
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sensoptic SA
Total Hip Arthroplasty, Degenerative Joint Disease of Hip
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and…
- Conditions
- Total Hip Arthroplasty, Degenerative Joint Disease of Hip, Avascular Necrosis of Hip, Rheumatoid Arthritis of Hip
- Trial name
- NCT04754087
- Testing
- Vivacit-E and Longevity (HXLPE) Liners
- Where
- 11 sites in United States, Denmark and 3 more
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
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.
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
Freezing of Gait Symptoms in Parkinson Disease
A System to Help With Freezing of Gait in Parkinson's Patients
The goal of this clinical trial is to learn if the ParkinSense system, a customizable, multimodal, and adaptable cueing system, can assist with freezing of gait (FOG) in patients with Parkinson's disease.
- Trial name
- NCT07542743
- Testing
- ParkinSense System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Barron Associates, Inc.
CT Guided Biopsy, CT Guided Drain Placement Within the Abdomen or Pelvis
Ultrasound-CT Fusion System for Interventional Radiology Procedures
The objective of this research is to use the Clear Guide SCENERGY technology, an FDA approved Ultrasound-CT fusion imaging system, that allows the user to fuse CT images onto a real-time ultrasound that is being performed on the…
- Conditions
- CT Guided Biopsy, CT Guided Drain Placement Within the Abdomen or Pelvis, CT Guided Injection of Muscle or Nerve Within the Pelvis
- Trial name
- NCT03226535
- Testing
- Ultrasound-CT Fusion
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Clear Guide Medical
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
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
Percutaneous Access
Feasibility of Robotic Instrument Guidance System to Perform Safe Ultrasound-Guided Percutaneous Procedures During Routine Medical Procedures.
The Mendaera Guidance System ("Study Device") is intended to provide guidance for precise instrument placement of common percutaneous devices by positioning the device relative to the ultrasound transducer and the resulting image…
- Trial name
- ACCESS (NCT07358351)
- Testing
- Mendaera Guidance System
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Mendaera, Inc
Degenerative Disc Disease, Degenerative Spondylolisthesis
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00996073
- Testing
- Lumbar Interbody Fusion with Autograft, Lumbar Interbody Fusion with NeoFuse
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Mesoblast, Ltd.
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
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.