Clinical trials: Safety and Performance
Bone Substitutes
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant
Multi-center, prospective, open-label, single-arm, first-in-human clinical investigation. The patient enrollment will be as follow: initial 5 patients enrolled at PI site.
- Trial name
- GreenBric (NCT03836404)
- Testing
- Iliac crest reconstruction surgery
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- GreenBone Ortho S.p.A.
Healthy Subjects
Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part I
The purpose of this clinical investigation is to test the safety and performance of short- and longterm Baseplates constructed with different types of biocompatible adhesives.
- Trial name
- NCT05111847
- Testing
- Short-term Baseplates first then long-term Baseplates, Long-term Baseplates first then short-term Baseplates
- Where
- Denmark
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- UNEEG Medical A/S
Atrial Fibrillation
Evaluation of the Safety and Efficacy of a Novel SeaLA™ Left Atrial Appendage Occluder
This study adapted a prospective, multicenter single-group objective performance criteria design. A total of 163 patients with non-valvular atrial fibrillation were enrolled in the clinical trial，follow up were scheduled in 7…
- Trial name
- NCT05911685
- Testing
- SeaLA™ left atrial appendage occluder
- Where
- China
- Volunteers
- 163 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Left Atrial Appendage Aneurysm
K2 Medical KALPA X™ Mapping, Imaging and Navigation Device
This prospective, multi-center, non-randomized, single-blinded, open-label, single-arm, comparator study will enroll up to 100 eligible subjects from multiple sites undergoing LAAC procedure to evaluate the safety and performance…
- Trial name
- NCT05155943
- Testing
- KALPA X™
- Where
- 2 sites in Italy, Lithuania
- Volunteers
- 18 people
- Sponsor
- Cara Medical Ltd
Stoma Ileostomy
Safety and Performance of New 1-piece Ostomy Product
The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.
- Trial name
- NCT01800916
- Testing
- Coloplast Adhesive baseplate A, Coloplast Adhesive baseplate B, Coloplast Adhesive baseplate C
- Where
- Denmark
- Volunteers
- 65 people
- Sponsor
- Coloplast A/S
Non-Squamous Non-Small Cell Lung Cancer
An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)
This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of…
- Trial name
- ELEMENT (NCT01836133)
- Testing
- Erlotinib 150 mg
- Where
- 5 sites in Serbia
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Hemorrhage, Blood Loss
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous…
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Trial name
- i-TRANSEP (NCT04588350)
- Testing
- i-SEP autotransfusion system
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- i-SEP
Ptosis, Ptosis, Mild
Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients With Mild to Moderate Facial Ptosis.
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SPRING THREAD® elastic tensor thread.
- Trial name
- ESTES (NCT05746078)
- Where
- 2 sites in France
- Volunteers
- 99 people
- Sponsor
- 1st SurgiConcept
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
Dry Eye
Performance and Safety of T2769 in DED
To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment. To evaluate the performance and safety of T2769 versus Vismed® Multi.
- Trial name
- NCT05965778
- Testing
- T2769, Vismed® Multi
- Where
- France
- Volunteers
- 251 people
- Sponsor
- Laboratoires Thea
Visual Functions
Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro
EyeSwift Pro assessment of visual function parameters as measured by psychophysics
- Trial name
- NCT05382676
- Testing
- Eyeswift Pro
- Volunteers
- 500 people
- Sponsor
- NovaSight
Wounds
A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
In the course of this clinical trial, it was shown that the use of Granudacyn/VERIFORTE med wound irrigation solution in the course of adjuvant therapy supports wound healing through mechanical irrigation and moistening of the…
- Trial name
- NCT06083740
- Testing
- Granudacyn/Veriforte
- Where
- Austria
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- P.G.F. Industry Solutions GmbH
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.
- Conditions
- Coronary Artery Disease, Atherosclerosis of Coronary Artery, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOMAG-LL (NCT07091682)
- Testing
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Where
- 14 sites in Germany, Hungary and 5 more
- Volunteers
- 100 people
- Sponsor
- Biotronik AG
Aortic Valve Stenosis, Heart Valve Diseases
JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT02732691
- Testing
- JenaValve Pericardial TAVR System
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- JenaValve Technology, Inc.
Leg Ulcer, Diabetic Foot Ulcer
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e.
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Surgical Wound
- Trial name
- GELFI (NCT05148390)
- Testing
- Cutimed® Gelling Fiber
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- BSN Medical GmbH
Acute Ischemic Stroke
Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients
The main objective of this clinical trial is to evaluate of the safety \& efficacy of the Ceretrieve device within 24 hours post thrombectomy procedure.
- Trial name
- NCT06733246
- Testing
- Aspiration 0
- Where
- Germany
- Volunteers
- 132 people
- Sponsor
- Ceretrieve Ltd.
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.
- Trial name
- NCT07379112
- Testing
- Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
- Volunteers
- 500 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Diaphragm Pacing
Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures
Feasibility study to advance the development of NeuRx Diaphragm Pacing System (DPS) for the intended use of stimulating the diaphragm to provide respiratory assistance in patients at risk of prolonged mechanical ventilation in…
- Trial name
- NCT02410798
- Testing
- TransLoc electrode
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Synapse Biomedical
TMJ Disc Disorder, TMJ Pain
MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ
The objective of this retrospective consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the JuggerKnot Mini Soft Anchor (implant and instrumentation) when used for soft tissue…
- Conditions
- TMJ Disc Disorder, TMJ Pain, TMJ Sounds on Opening/Closing the Jaw, TMJ Disease
- Trial name
- NCT04033692
- Testing
- JuggerKnot Mini Soft Anchor
- Volunteers
- healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Atrial Fibrillation
Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation
Atrial fibrillation is associated with increased risk of stroke mostly because of clot formation in the left atrial appendage, a small alcove in the left atrium heart chamber.
- Trial name
- NCT03526471
- Testing
- Omega™ Left Atrial Appendage (LAA) Occluder
- Where
- 2 sites in Denmark, Thailand
- Volunteers
- 20 people
- Sponsor
- Vascular Innovations Co. Ltd.
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