Clinical trials: Safety and Performance
Ileostomy - Stoma
Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece
The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
- Trial name
- NCT01957488
- Testing
- Coloplast Test Product 1, Coloplast Test Product 2, Coloplast SenSura
- Where
- 4 sites in Denmark, Netherlands and 2 more
- Volunteers
- 183 people
- Sponsor
- Coloplast A/S
Pulmonary Hypertension
Acute Assessment of the Aria CV System in Patients With WHO Groups 2 and 3 Pulmonary Hypertension
This study is a prospective, non-randomized, two arm, single-center acute feasibility study assessing safety and performance of the Aria CV Acute PH System in WHO Group 2 and 3 PH patients.
- Trial name
- NCT05001711
- Testing
- Aria CV Acute PH System
- Where
- Austria
- Volunteers
- 18 people
- Sponsor
- Aria CV, Inc
Dentistry, Dental Implant
Performance and Safety Use of the Mono Block Implant "KONTACT MB"
A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue…
- Conditions
- Dentistry, Dental Implant, Dental Restoration, Implant-supported Fixed Prosthesis
- Trial name
- NCT05016258
- Testing
- KONTACT MB
- Where
- France
- Volunteers
- 159 people
- Sponsor
- Biotech Dental
Bone Defects, Orthopaedic Surgery (30 Minutes or Longer)
Evaluation of the Safety and Performance of the Neocement®
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® when used according to its intended purpose and current clinical applications.
- Trial name
- Neocement01 (NCT06973226)
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Bioceramed
Refractory Paroxysmal Atrial Fibrillation
A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug…
- Trial name
- AFIRE (NCT05552963)
- Testing
- Multi-Channel Irreversible Electroporation (IRE) Generator, Multi-Channel Circular IRE Catheter
- Where
- 6 sites in China
- Volunteers
- 142 people
- Sponsor
- Biosense Webster, Inc.
Neurologic Disorder, Healthy
Establishment of Delphi-MD Safety Performance and Reliability
A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation (TMS) Evoked Potentials (TEPs) as…
- Trial name
- NCT06368024
- Testing
- This is a retrospective analysis study of data collected with a diagnostic medical device
- Where
- Israel
- Volunteers
- 263 people, healthy volunteers welcome
- Sponsor
- QuantalX Neuroscience
Aortic Coarctation, Pulmonary Artery Stenosis
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
This study evaluates the safety and effectiveness of the CardiaZn stent, a novel bioresorbable stent designed specifically for infants and children with congenital cardiovascular conditions.
- Trial name
- Pediasorb (NCT07628101)
- Testing
- CardiaZn Bioresorbable Stent
- Volunteers
- 45 people
- Sponsor
- PediaStent LLC
Glaucoma, Open Angle Glaucoma
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
- Trial name
- NCT04773106
- Testing
- ARGOS-SC suprachoroidal pressure sensor
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 22 people
- Sponsor
- Implandata Ophthalmic Products GmbH
In-stent Restenosis, Stent Fracture
Pilot Study of the α Prototype NIMBLE System: Feasibility, Safety, and Initial Performance in Non-Invasive Detection of Coronary In-Stent Restenosis
The NIMBLE-I study is a prospective, unicentric, single arm, feasibility clinical trial designed to evaluate a novel medical device for the non-invasive monitoring of coronary stents.
- Conditions
- In-stent Restenosis, Stent Fracture, Stent Complication
- Trial name
- NIMBLE-I (NCT06968858)
- Testing
- NIMBLE test
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nimble Diagnostics S.L.
Blister
Hydrogel Blister Patch Prototype Treatment for Foot Blisters on the Heel
Study to evaluate the safety and performance of a new blister patch intended to treat blisters on the heel of the foot.
- Trial name
- NCT01088685
- Testing
- Experimental Blister Patch, Marketed Pflaster
- Where
- Germany
- Volunteers
- 93 people
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
Respiratory Failure, Respiratory Insufficiency
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
Randomized, control crossover study comparing Umbulizer's efficacy to traditional mechanical ventilators
- Conditions
- Respiratory Failure, Respiratory Insufficiency, Respiratory Arrest
- Trial name
- NCT04030208
- Testing
- Umbulizer, Traditional Mechanical Ventilator
- Where
- Pakistan
- Volunteers
- 24 people
- Sponsor
- Umbulizer LLC
Opthalomology/Dry Eye
An Interventional, Confirmative, Post Marketing Clinical Followup (PMCF) Study to Evaluate Performance and Safety of Ophthalmic Solutions Used to Relieve Dry Eyes Like Symptoms in Glaucoma Patients.
Study Rationale: The glaucomas are a group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells.
- Trial name
- M-GLAU-01-2020 (NCT05773976)
- Testing
- Afomill Refreshing Soothing, Afomill Anti-redness Eye Drops, Iridil
- Where
- 2 sites in Italy
- Volunteers
- 59 people
- Sponsor
- Montefarmaco OTC SpA
Shoulder Pain, Shoulder Injuries
MDR - Comprehensive Primary Revision Stems PMCF
The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary…
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease
- Trial name
- NCT06788717
- Testing
- Comprehensive Primary Revision Stems
- Where
- 2 sites in United States, Denmark
- Volunteers
- 59 people
- Sponsor
- Zimmer Biomet
Pancreatectomy, Hepatic Resection
Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage in Hepatobiliary and Pancreatic Surgery
Polyganics BV (Groningen, The Netherlands), in close collaboration with University Hospital-Eppendorf (UKE) Hamburg, has developed the Sealing Device for use in hepato-pancreato-bilary (HPB) surgery to reduce leakage of fluids…
- Trial name
- SHIELDS (NCT04024956)
- Testing
- Sealing Device
- Where
- 2 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Polyganics BV
Allergic Rhinitis
Sterimar Allergic Rhinitis
The study aims to confirm the safety and performance of a hypertonic seawater-based nasal spray enriched with manganese and calcium, in relief/reduction of nasal symptoms (congestion, itchy nose, runny nose and sneezing) among…
- Trial name
- NCT05506709
- Testing
- Seawater nasal spray
- Where
- Armenia
- Volunteers
- 59 people
- Sponsor
- Church & Dwight Company, Inc.
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System
The PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with…
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Poor Vascular Access
- Trial name
- NCT06037265
- Testing
- PAVmed PortIO™ Intraosseous Infusion System
- Where
- 4 sites in Colombia
- Volunteers
- 15 people
- Sponsor
- PAVmed Inc.
Stress Urinary Incontinence
Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)
This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking.
- Trial name
- DRY (NCT04827199)
- Testing
- Artificial Urinary Sphincter implantation
- Where
- 3 sites in Czechia, Spain
- Volunteers
- 70 people
- Sponsor
- Myopowers Medical Technologies France SAS
Clear Cell Renal Cell Carcinoma
89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON…
- Trial name
- NCT06750419
- Testing
- 89Zr-TLX250 PET/CT
- Where
- 8 sites in China
- Volunteers
- 82 people
- Sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
Stoma Ileostomy
Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy
The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.
- Trial name
- CP257 (NCT02887144)
- Testing
- SenSura, SenSura test product
- Where
- Denmark
- Volunteers
- 72 people
- Sponsor
- Coloplast A/S
Refractive Ametropia
A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
13 weeks, open-label, daily disposable contact lens dispensing study.
- Trial name
- NCT07322211
- Testing
- Treatment
- Where
- 2 sites in Taiwan
- Volunteers
- 35 people
- Sponsor
- Unicon Optical Co. Ltd.
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