Clinical trials: Device
Chronic Low-back Pain, Degenerative Disc Disease
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome
- Trial name
- ARREST (NCT05944081)
- Testing
- ArcadiusXP L® Interbody Fusion System
- Where
- 3 sites in Germany
- Sponsor
- Aesculap AG
Coronary Arterial Disease (CAD)
FORWARD CAD IDE Study
The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the…
- Trial name
- NCT06662500
- Testing
- Intravascular Lithotripsy
- Where
- 34 sites in United States, United Kingdom
- Volunteers
- 408 people
- Sponsor
- Shockwave Medical, Inc.
Healthy
Open-label, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects
This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg when injected by means of a prefilled…
- Trial name
- NCT02806219
- Testing
- Prefilled syringe (PFS), e-Device
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- UCB BIOSCIENCES, Inc.
Colorectal Polyps
Clinical Trial to Evaluate the Efficacy and Safety of SUBMO® as a Submucosal Injection Agent in Endoscopic Resection of Superficial Gastrointestinal Lesions.
The SUBMO-PIC01-2025 study evaluates whether SUBMO®, a submucosal injection hydrogel composed of high-molecular weight hyaluronic acid and methylene blue, is as effective and safe as normal saline for endoscopic resection of…
- Trial name
- NCT07448129
- Testing
- SUBMO® Submucosal Injection, Normal Saline (0.9% Sodium Chloride) with Surface Dye Injection
- Where
- 4 sites in Spain
- Volunteers
- 300 people
- Sponsor
- i+Med S.Coop.
Stroke, Cerebrovascular Accident
AMES Treatment of the Impaired Leg in Chronic Stroke Patients
The purpose of this protocol is to determine if individuals who had a stroke more than one year before entering the study and whose ankles remain substantially impaired are able to sense and move the affected leg better after…
- Conditions
- Stroke, Cerebrovascular Accident, Hemiparesis
- Trial name
- AMES (NCT01378637)
- Testing
- AMES- Leg treatment
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- AMES Technology
Myopia
Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
This is a prospective, randomized, controlled, contralateral eye, clinical study. The objective of the study is to determine the impact of Virtual Reality (VR) usage on choroidal thickness when viewed through a test display…
- Trial name
- MIRABILE (NCT04140877)
- Testing
- Visu
- Volunteers
- healthy volunteers welcome
- Sponsor
- Visu, Inc.
Ventricular Tachycardia, Arrythmia
Rook Epicardial Access Device Study
The purpose of this study is to confirm the efficacy and safety of the Talon Surgical Rook® Epicardial Access Kit as a pericardial access device.
- Trial name
- NCT03427333
- Testing
- The Rook® Epicardial Access Kit
- Where
- Czechia
- Volunteers
- 13 people
- Sponsor
- Talon Surgical
Cataract
Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)
Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.
- Trial name
- NCT02782676
- Testing
- Investigational Healon5 OVD, Healon5 OVD
- Volunteers
- 241 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Optics
Overweight or Obesity
Examination of Circumferential Reduction
The rationale for the selection of Outcome Measures is the compliance with FDA regulations as pertain to medical devices with a moderate level of risk of hazard leading to harm of the patient; firstly, the safety of the device in…
- Trial name
- NCT04451824
- Testing
- CL-100
- Where
- 3 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Contour Research
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone
This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome
- Trial name
- NCT01327924
- Testing
- Norditropin NordiFlex®
- Where
- France
- Volunteers
- 77 people
- Sponsor
- Novo Nordisk A/S
Stroke, Chronic Stroke
Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke
A single-site, interventional, single-arm trial to evaluate the safety and efficacy on functional mobility following Samsung GEMS-H (Gait Enhancing and Motivating System - Hip) device training in participants with sub-acute and…
- Trial name
- NCT04285060
- Testing
- Samsung GEMS-H
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Samsung Electronics
Atrial Fibrillation
Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation.
DISPLAY-AF is a prospective, multicenter, single-arm post-market clinical follow-up investigation designed to evaluate whether spatiotemporal dispersion areas identified by the Volta AF-Xplorer II artificial intelligence (AI)…
- Trial name
- DISPLAY-AF (NCT07807423)
- Testing
- Complete biatrial mapping
- Where
- 5 sites in France
- Volunteers
- 125 people
- Sponsor
- Volta Medical
No Disease or Condition is Being Studied
Evaluation of the Performance and Safety of VACUSERA® PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma
Study Design After the eligibility assessment during screening and obtaining a written informed consent form, the volunteers' demographic information and medical history will be recorded.
- Trial name
- PRP (NCT07041918)
- Testing
- The study is entirely designed to analyze product performance (analyze only results from whole blood and derived from the PRP tubes), and no interventions will be performed.
- Where
- Turkey (Türkiye)
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Disera Tıbbi Cihazlar Lojistik Sanayi ve Ticaret A.Ş
Cluster Headache
A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache.
The study will look at a non-invasive treatment for people suffering with chronic and episodic headaches. Study subjects will be randomized to an active treatment or an in-active treatment for 2 weeks.
- Trial name
- NCT01958125
- Testing
- gammaCore
- Where
- 9 sites in Denmark, Germany and 2 more
- Volunteers
- 102 people
- Sponsor
- ElectroCore INC
Septic Shock
A RCT to Assess the Performance of CytoSorb for Shock Reversal in Patients With Vasoplegic Septic Shock
To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock.
- Trial name
- PROCYSS (NCT04963920)
- Testing
- Cytosorb® 300 ml
- Where
- 18 sites in Germany
- Volunteers
- 260 people
- Sponsor
- CytoSorbents Europe GmbH
Diabetes Mellitus
Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes
This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance…
- Trial name
- NCT04126759
- Testing
- P0.3
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- RSP Systems A/S
Obsessive-Compulsive Behavior
rTMS Device for Improvement of Obsessive and Compulsive Behaviors
The goal of this investigational study is to evaluate if the treatment using EXOMIND(BTL-699-2) device is able to improve severity of obsessive and compulsive symptoms in adults (aged 22 and older).
- Trial name
- NCT07679750
- Testing
- EXOMIND (BTL-699-2) Active treatment
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- BTL Industries Ltd.
Abdominal Fat
Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction
A long-term follow-up study to evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.
- Trial name
- NCT03428243
- Testing
- truSculpt
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Cutera Inc.
Abdominal Aortic Aneurysm
Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)
The objective of this study is to assess the safety and effectiveness of the Cordis Bilateral AAA device and its Delivery System compared to open surgical repair for the treatment of Abdominal Aortic Aneurysm (AAA).
- Trial name
- NCT00235118
- Testing
- Cordis AAA Bilateral Device
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Cordis US Corp.
Body Sculpting
A Multicenter Controlled Study to Evaluate Efficacy and Safety of Focused Ultrasound Device (FUBA5200) for Noninvasive Fat Reduction
This clinical trial is a prospective, multicenter, randomized blinded, parallel controlled study. The purpose of this study is to evaluate the efficacy and safety of the Focused UltrasoundDevice (FUBA5200) for Fat Reduction.
- Trial name
- NCT06017648
- Testing
- Non Invasive Ultrasound (FUBA5200), Non Invasive Ultrasound (Contour I V3)
- Where
- 3 sites in China
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Shanghai Carnation Medical Technology Co., Ltd