Clinical trials: Medical Device Performance
Total Knee Arthroplasty
Comparison of Intraoperative Warming Devices
The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee…
- Trial name
- NCT00711867
- Testing
- VH2, Bair Hugger
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Mayo Clinic
Vascular Access Complications
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
- Trial name
- NCT01940354
- Testing
- AccuCath IV Catheter System, Conventional IV Catheter System
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Hearing Loss, Sensorineural
Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear
Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant.
- Trial name
- NCT03867396
- Testing
- CROS, Hearing Aid, Cochlear Implant Alone
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Colorado, Denver
Acetabulum Fracture, Pelvic Ring Fracture
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System
The study is a monocentric, retrospective, 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 Reconstruction System…
- Trial name
- NCT05215626
- Where
- Italy
- Volunteers
- 78 people
- Sponsor
- Zimmer Biomet
Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA.
- Conditions
- Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Correction of Functional Deformity
- Trial name
- NCT03409666
- Testing
- Taperloc Complete Microplasty stem, Taperloc Complete Reduced Distal stem
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet
Glaucoma
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg…
- Trial name
- NCT00772330
- Testing
- Glaucoma Drainage Device
- Where
- Dominican Republic
- Volunteers
- 23 people
- Sponsor
- InnFocus Inc.
Parkinson's Disease (PD)
Observational Study Evaluating Robotic Spinal Mobilization in 16 Parkinson's Disease Participants. The Study Recorded Changes in Mobility, Sit-to-stand Performance, and Pain Scores After a 2-week Intervention With the BackHug Device.
The goal of this completed observational pilot study was to evaluate the immediate and short-term clinical effects of robotic spinal mobilization on motor and non-motor symptoms in community-dwelling adults with Parkinson's…
- Trial name
- NCT07384364
- Where
- United Kingdom
- Volunteers
- 19 people
- Sponsor
- Pacla Medical Limited
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
Breast Cancer
CairnSurgical Breast Cancer Locator (BCL) Post-Market Study
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in…
- Trial name
- NCT06461663
- Testing
- Breast Cancer Locator Guided Breast Conserving Surgery
- Where
- 6 sites in Germany, Italy and 1 more
- Volunteers
- 35 people
- Sponsor
- CairnSurgical, Inc.
Rotator Cuff Tears, Rotator Cuff Injuries
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study.
- Trial name
- NCT05690776
- Where
- 2 sites in France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
Low Back Pain
Technical Efficacy of a Direction Specific Radiofrequency Device in the Performance of Lumbar Medial Branch Neurotomies
The purpose of this study is to document the effectiveness of the Nimbus Multi-tined Expandable Electrode (MEE) Probe in carrying out the heating and ablation (cutting) of the small medial branch nerves that carry pain…
- Trial name
- NCT02120625
- Testing
- Lumbar MB RFN
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Nimbus Concepts, LLC
Prostate Cancer
Global Performance Evaluation of the AMS CONTINUUM™ Device
1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure. 2.
- Trial name
- NCT01083199
- Testing
- CONTINUUM™
- Where
- 2 sites in Greece, Spain
- Volunteers
- 10 people
- Sponsor
- American Medical Systems
Percutaneous CFA Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device FIV
The purpose of this Clinical Investigation Plan (CIP) is to: 1. Confirm the safety and performance of the PerQseal® large hole closure system. 2.
- Trial name
- Frontier-IV (NCT03423602)
- Testing
- PerQseal®
- Where
- 11 sites in Germany, Ireland
- Volunteers
- 75 people
- Sponsor
- Vivasure Medical Limited
Burns
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review.
- Trial name
- NCT03333941
- Testing
- ReCell® Autologous Cell Harvesting Device
- Where
- 6 sites in United States
- Volunteers
- 76 people
- Sponsor
- Avita Medical
Pulmonary Disease, Chronic Obstructive
Ventilator Adapters for Combivent Respimat
The general aim of this 1-day, open label, non-randomised, trial is to characterize the performance of two adapter devices designed to permit use of the Respimat® inhaler with patients requiring mechanical ventilation.
- Trial name
- NCT01969539
- Testing
- Combivent Respimat via tee adapter, Combivent Respimat via ventilator adapter
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Boehringer Ingelheim
Visual Performance
Investigation of Ocular Signs & Symptoms in Wearers Fitted With Contact Lenses Following Digital Device Use
The objective of this study is to assess how various silicone hydrogel lenses perform when worn by subjects who are heavy digital device users.
- Trial name
- NCT02394756
- Testing
- Marketed Soft Contact lens, AIR OPTIX® AQUA, Biofinity®
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Vision Care, Inc.
Bone Substitutes, Bone Defect
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects…
- Trial name
- NCT03884790
- Testing
- surgical repair of long bone defects
- Where
- 8 sites in Bosnia and Herzegovina, Israel and 4 more
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.
Device Validation of In-vivo Performance
An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.
- Trial name
- NCT05239455
- Testing
- Reveos® Automated Blood Processing System
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Acute Concussion Syndrome
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
This is a controlled investigation, with randomization of the patients, which aims at evaluating the safety and performance of device RGn550 in treating sportspeople suffering from acute concussion syndrome.
- Trial name
- RECOVERY (NCT05647304)
- Testing
- RGn550 5 Hz-PWM, RGn550 10 Hz-PWM
- Where
- France
- Volunteers
- 50 people
- Sponsor
- REGEnLIFE SAS
Small Bowel Disease
A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy
The objective of the SAMISEN study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral).
- Trial name
- SAMISEN (NCT03955081)
- Testing
- Deep enteroscopy
- Where
- 10 sites in Belgium, Denmark and 4 more
- Volunteers
- 302 people
- Sponsor
- Olympus Europe SE & Co. KG