Clinical trials: Medical Device Performance
Thoracic Diseases
Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine…
- Trial name
- SURPASS (NCT03286400)
- Testing
- CTAG Device with ACTIVE CONTROL
- Where
- 20 sites in France, Germany and 5 more
- Volunteers
- 127 people
- Sponsor
- W.L.Gore & Associates
Chronic Heart Failure, Edema
AquaPass Device in Treatment of CHF Patients
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.
- Conditions
- Chronic Heart Failure, Edema, CHF
- Trial name
- NCT05843201
- Testing
- The AquaPass System
- Where
- 2 sites in Israel
- Volunteers
- 18 people
- Sponsor
- AquaPass Medical Ltd.
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
Overweight or Obesity
Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®
The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia.
- Trial name
- SHINE (NCT06087822)
- Testing
- IMD SiPore21®
- Where
- 27 sites in Poland, Romania and 1 more
- Volunteers
- 318 people
- Sponsor
- Sigrid Therapeutics AB
Onychomycosis
Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis
Based on manufacturer testing, no major difference in drilling condition is expected in this study compared to the drilling conditions previously established.
- Trial name
- NCT00941317
- Testing
- Pathformer (micro-drilling device)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Galderma R&D
Diabetes Mellitus
Performance Study of a Non-invasive Glucose Monitoring Device Prototype
This clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in private homes of subjects.
- Trial name
- NCT03519841
- Testing
- P0.1
- Where
- Denmark
- Volunteers
- 6 people
- Sponsor
- RSP Systems A/S
Hepatic Tumor
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
- Trial name
- NCT04230642
- Testing
- The Quantum Surgical device
- Where
- 2 sites in France
- Volunteers
- 22 people
- Sponsor
- Quantum Surgical
Acute Upper Gastrointestinal Hemorrhage, Acute Upper Gastrointestinal Bleeding
Clinical Investigation of Safety and Performance of a Medical Device (ClearPlasma) for the Treatment of Patients With Acute Upper Gastrointestinal Hemorrhage.
Pre-market, multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation of a Class IIb Investigational Medical Device, in which Patients presenting with acute upper…
- Trial name
- NCT04174989
- Testing
- Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device), Regular fresh-frozen plasma (not treated)
- Where
- 8 sites in Czechia, Israel and 1 more
- Volunteers
- 53 people
- Sponsor
- PlasFree Ltd.
Diabetes Mellitus
Study of a Non-invasive Glucose Measuring Device
This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.
- Trial name
- NCT05851469
- Testing
- Prototype 0.5
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- RSP Systems A/S
Low Back Pain, Recurrent
Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain
The main objective of this clinical investigation is to show the superiority of a rehabilitation based on the use of Blueback® Physio compared to a rehabilitation without the use of Blueback® Physio in terms of reducing the time…
- Trial name
- ABC-TRACC (NCT04592094)
- Testing
- Blueback® Physio
- Where
- France
- Volunteers
- 42 people
- Sponsor
- Blueback
Intra Abdominal Pressure, Intra-Abdominal Hypertension
Intra-gastrointestinal Monitoring Device (PressureDOT®) and Centurion IAP Monitoring Device Comparison Study: Pivotal Study of Safety and Performance.
The proposed clinical study protocol is intended to establish the safety, utility, and reliability of using a pressure-sensing capsule present in a patient's gastrointestinal tract for monitoring intraabdominal pressure (IAP).
- Trial name
- NCT07400666
- Testing
- digital capsule
- Volunteers
- 26 people
- Sponsor
- Dotspace Inc.
Trapeziometacarpal Osteoarthritis, Rhizarthrosis
Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS
Collagen is a structural protein biopolymer consisting of three polypeptide chains wrapped around to form a right-handed triple helix.
- Conditions
- Trapeziometacarpal Osteoarthritis, Rhizarthrosis, MEDICAL DEVICE, Infiltrate
- Trial name
- SMAGENART (NCT06781554)
- Testing
- MD-Small Joints Collagen Medical Device
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- Guna S.p.a
Osteoarthritis Shoulder, Fracture
Multi Centre Study on TESS V2 Shoulder System
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
- Conditions
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis
- Trial name
- NCT03431857
- Testing
- TESS V2
- Where
- 2 sites in Belgium, France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
Bacterial Vaginosis
Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis
The aim of this study is to find out how well the medical device Lactal Gel works and how safe it is. The product will be used to treat bacterial vaginosis in a group of fifty women aged 18 years or older.
- Trial name
- NCT07241871
- Testing
- Lactal Gel (Class IIa medical device)
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Rolf Kullgren AB
Atrial Fibrillation
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that…
- Trial name
- NCT06099106
- Testing
- SEPIOLA System
- Where
- 5 sites in Georgia, Lithuania and 2 more
- Volunteers
- 15 people
- Sponsor
- Endomatic Ltd.
Potassium Measurement
GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.
Multicentre, open, prospective and interventional study investigating the CardioRenal device in capillary blood of patients.It will be conducted at multiple investigational sites.
- Trial name
- NCT05975632
- Testing
- Device: Self testing Potassium device
- Where
- 6 sites in France
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- CardioRenal
Intracranial Aneurysm
Safety & Performance of the World Medica World Diverter Embolization Device
The objective of this study is to investgiate the safety and clinical performance of the World Diverter Emoblization Device for the endovascular treatment of wide-neck (neck width ≥ 4 mm or dome-to-neck ratio <2) or fusiform…
- Trial name
- NCT07339358
- Testing
- Flow diverter implantation
- Where
- Spain
- Volunteers
- 72 people
- Sponsor
- World Medica USA, LLC
Aging, Heart Failure
Stair Descending vs. Stair Ascending Exercise
The aim of the present project is to compare the acute and chronic effect of stair descending versus stair ascending exercise on muscle damage and performance in elderly males with chronic heart failure.
- Conditions
- Aging, Heart Failure, Sarcopenia
- Trial name
- NCT01673958
- Testing
- Exercise
- Where
- Cyprus
- Volunteers
- 12 people
- Sponsor
- European University Cyprus
Nevus, Multiple Nevi
Study of the Nevisense Device to Assess Atypical Skin Lesions
The purpose of this study is to find out whether the Nevisense device can provide useful information about atypical moles to complement the usual assessments done during routine screening for melanoma.
- Conditions
- Nevus, Multiple Nevi, Large Acquired Nevi, Skin Lesion
- Trial name
- NCT04705168
- Testing
- Nevisense electrical impedance spectroscopy
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Upper Limb Amputation
Functional Performance of Voluntary Opening and Closing Body Powered Prostheses
This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses.
- Trial name
- NCT02136238
- Testing
- Hosmer 5XA voluntary opening hook, TRS Grip 3 voluntary closing hook
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of South Florida