Clinical trials: Safety and Performance
Cardiac Arrhythmia
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available…
- Trial name
- NCT05301803
- Testing
- Electrophysiology procedure
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- CathVision ApS
Hearing Loss
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751.
- Trial name
- NCT04754477
- Testing
- Active Osseointegrated Steady-State Implant System (OSI)
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 20 people
- Sponsor
- Cochlear
Lung Cancer
EPIONE Guided Lung Evaluation
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.
- Trial name
- EGLE (NCT05651867)
- Testing
- EPIONE device
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Quantum Surgical
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
Femoral Arteriotomy Closure
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of…
- Trial name
- NCT02521948
- Testing
- MANTA Vascular Closure Device
- Where
- 3 sites in Italy, Netherlands
- Volunteers
- 50 people
- Sponsor
- Essential Medical, Inc.
Tachycardia, Ventricular Fibrillation
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
- Conditions
- Tachycardia, Ventricular Fibrillation, Ventricular Flutter
- Trial name
- NCT01856491
- Testing
- RELIANCE 4-FRONT™ Passive Fixation lead implantation
- Where
- 11 sites in Germany, Israel and 1 more
- Volunteers
- 167 people
- Sponsor
- Boston Scientific Corporation
Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal
Evaluation of the Bifurcated Multilayer Flow Modulator for the Treatment of Abdominal Aortic Aneurysm
The study purpose is to determine the safety and efficacy of the BMFM used for the endovascular treatment of aortic aneurysm involving iliac arteries.
- Trial name
- STREAMLINER (NCT03024554)
- Testing
- Implantation of the Bifurcated Multilayer Flow Modulator
- Where
- 7 sites in Belgium, Bulgaria and 3 more
- Volunteers
- 42 people
- Sponsor
- Cardiatis
Restless Legs Syndrome
Simulated Driving Study in Restless Legs Syndrome
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS).
- Trial name
- XP083 (NCT01332318)
- Testing
- XP13512, Diphenhydramine
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- XenoPort, Inc.
Carotid Artery Diseases, Stroke
Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with…
- Trial name
- WISE (NCT01783639)
- Testing
- Carotid Artery Stent
- Where
- 10 sites in Belgium, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- Gardia Medical
Incontinence, Urge
T-DOC® 5 Fr Pediatric Clinical Investigation
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
- Trial name
- NCT03429270
- Testing
- TDOC 5Fr
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Surgical Scar, Breast Augmentation
Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift.
- Conditions
- Surgical Scar, Breast Augmentation, Abdominoplasty, Face Lift
- Trial name
- NCT03467724
- Testing
- Fractional Radiofrequency (FRF)
- Where
- Spain
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Sore-throat, Cough
The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study
Demulcent or soothing substance is the currently recommended option to alleviate throat irritation associated to cough and sore throat in children under 6 years.
- Trial name
- Touxpetit (NCT06688370)
- Testing
- Petit Drill
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Pierre Fabre Medicament
Non-valvular Atrial Fibrillation
The Conformal Prague Study
A prospective, single center, open-label, single arm, study to evaluate the safety and technical performance of the CLAAS system for closure of the left atrial appendage.
- Trial name
- NCT04193826
- Testing
- Left Atrial Appendage Closure
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- Conformal Medical, Inc
Leakage, Skin Condition
Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.
- Trial name
- NCT01517178
- Testing
- New ostomy base plate (SS), Standard Care base plate
- Where
- 11 sites in Denmark, France and 2 more
- Volunteers
- 33 people
- Sponsor
- Coloplast A/S
Polyp of Colon, Endoscopic Mucosal Resection
EndoRotor® Endoscopic Mucosal Resection System for the Colon
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic…
- Conditions
- Polyp of Colon, Endoscopic Mucosal Resection, Recurrent Colon Adenoma
- Trial name
- NCT04203667
- Testing
- EndoRotor Resection
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 66 people
- Sponsor
- Interscope, Inc.
Injections, Intradermal
Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.
The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery devices can safely and precisely inject liquid into the intradermal layer of the skin in three different injection locations
- Trial name
- NCT01943110
- Testing
- ID adapter (autodisable), ID adapter (side load)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- PATH
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction
This will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.
- Trial name
- NCT01542502
- Testing
- Anakinra
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Virginia Commonwealth University
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