Clinical trials: Safety and Performance
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Eczema, Psoriasis
A Clinical Investigation With Epaderm® Cream
This investigation is designed as a prospective, non-randomised, single arm clinical investigation. Data is collected from approximately 120 evaluable subjects, divided into three groups of approximately 40 subjects; infants…
- Conditions
- Eczema, Psoriasis, Dry Skin; Eczema
- Trial name
- PD-539878 (NCT03738163)
- Testing
- Epaderm Cream
- Where
- 2 sites in United Kingdom
- Volunteers
- 121 people
- Sponsor
- Molnlycke Health Care AB
Aortic Valve Disease
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic…
- Trial name
- SAPIEN3 (NCT01808287)
- Testing
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Where
- 17 sites in Canada, France and 3 more
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Safety of the CytaCoat LIP Foley Catheter, Tolerability of the CytaCoat LIP Foley Catheter
Evaluation of Safety and Performance of the CytaCoat Lubricious Infection Prevention (LIP) Foley Catheter
The goal of this pilot safety and tolerability study is to determine whether the novel CytaCoat LIP (Lubricious Infection Prevention) Foley catheter is safe to use in patients during short term use.
- Trial name
- NCT06242600
- Testing
- Drainage of the bladder by indwelling Foley catheter
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- CytaCoat AB
Coronary Artery Disease
Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions
1.) Indigenously developed and designed BioMimeTM is a predictably safe \& efficacious 3rd generation drug eluting stent (DES) with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut…
- Trial name
- meriT-1 (NCT01507519)
- Testing
- Sirolimus Eluting Coronary Stent System (Biomime)
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Ureteral Diseases
Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.
- Trial name
- URIPRENE (NCT04565795)
- Testing
- Uriprene® Degradable Temporary Ureteral Stent
- Where
- 4 sites in United States
- Volunteers
- 87 people
- Sponsor
- Adva-Tec
Acquired Brain Injury (Including Stroke)
Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Acquired Brain Injury in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Exoskeleton device in people with acquired brain injury during a 10-session gait training program in a clinical setting.
- Trial name
- NCT07050875
- Testing
- ABLE Exoskeleton
- Where
- 3 sites in Spain
- Volunteers
- 14 people
- Sponsor
- ABLE Human Motion S.L.
Hemiplegia, Hemiparesis
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Stroke is a leading cause of disability in adults, with gait impairment being a key functional limitation. Although lower limb exoskeletons are used in rehabilitation, the available evidence focuses on bilateral devices used in…
- Trial name
- VAWAKE (NCT07867847)
- Testing
- Bionic System (AWAKE)
- Volunteers
- 20 people
- Sponsor
- Bionic Mobility Solutions, S.L.
Bowel Dysfunction
An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents
The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents.
- Trial name
- NCT06385249
- Testing
- Navina Mini
- Where
- Sweden
- Volunteers
- 27 people
- Sponsor
- Wellspect HealthCare
Peripheral Arterial Disease, Peripheral Arterial Disease(PAD)
Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)
The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.
- Trial name
- NCT06758921
- Testing
- Oscar Peripheral Multifunctional Catheter
- Where
- 16 sites in Austria, Belgium and 6 more
- Volunteers
- 200 people
- Sponsor
- Biotronik AG
Brain Tumor Adult, Epilepsy
WISE Cortical Strip for Intraoperative Neurophysiological Monitoring
The WIN Study is a prospective, interventional, multi-center, open-label premarket study designed to confirm the safety, performance and intended use of the WISE Cortical Strip (WCS) for CE certification purposes.
- Trial name
- WIN (NCT03731455)
- Testing
- WISE Cortical Strip
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 32 people
- Sponsor
- Wise S.r.l.
Vital Signs
A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application
This study validates Lifelight® First, a software application, in a laboratory setting. Participants will undergo testing to obtain measurements from one or more of the four vital signs.
- Trial name
- NCT03998098
- Testing
- Oxygen Saturation (Oximetry), Heart Rate (Pulse), Respiratory Rate
- Where
- United Kingdom
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Xim Limited
Atrial Fibrillation, Stroke Prevention
The GLACE Study: Evaluating CLAAS With ICE Guided LAA Closure
The CLAAS® device will be evaluated for safety and performance in the reduction of stroke in subjects with non-valvular atrial fibrillation under intracardiac echocardiography (ICE) imaging for left atrial appendage closure.
- Trial name
- NCT06580275
- Testing
- CLAAS
- Where
- 4 sites in Czechia, Denmark and 1 more
- Volunteers
- 67 people
- Sponsor
- Conformal Medical, Inc
Edentulous Mouth
In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Tissue Level Z1
Partial or total edentulousness has a significant impact on quality of life both functionally and aesthetically. TBR® Tissue Level Z1 Implants allow the patient to prevent bone resorption and maintain facial tissue and…
- Trial name
- Z1 (NCT04984499)
- Testing
- Dental implant
- Where
- France
- Volunteers
- 152 people
- Sponsor
- Sudimplant SAS - Groupe TBR
Rhinosinusitis Chronic, Wound Healing
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate
The objective of this study is to investigate the safety and performance of OCEAN® as an adjunct in wound healing after nasal/sinus surgery by using OCEAN® in patients undergoing nasal/sinus surgery.
- Conditions
- Rhinosinusitis Chronic, Wound Healing, Sinus Surgery, Mometasone Furoate
- Trial name
- ENHANCE (NCT06642116)
- Testing
- OCEAN
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Polyganics BV
Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs
Safety and Performance of PEEK Anchors in Extremities
Safety and performance of the study devices in extremities up to 12 months post-surgery
- Conditions
- Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- NCT03782298
- Testing
- Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL
- Where
- 4 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- Smith & Nephew, Inc.
Post-surgical Oral Wounds, Oral Cavity Surgery
Evaluation of the Performance and Safety of a Linear Hyaluronic Acid-Based Medical Device in the Treatment of Surgical Wounds in the Oral Cavity.
The PR-DENT study is an interventional, single-center, controlled clinical investigation aimed at evaluating the clinical performance and safety of a Class III medical device based on linear hyaluronic acid for the treatment of…
- Conditions
- Post-surgical Oral Wounds, Oral Cavity Surgery, Wound Healing/Regeneration, Dental Extraction Sites
- Trial name
- PR-DENT (NCT07421934)
- Testing
- Intervention: Linear Hyaluronic Acid (Gumblast), Control: Standard Surgical Procedure
- Where
- Italy
- Volunteers
- 28 people
- Sponsor
- The Wave Innovation Group s.r.l.
Obesity
NitiNotes' EndoZip System for the Treatment of Obesity
This is first-in-man safety and performance feasibility study, aimed to provide initial clinical assessment of safety and effectiveness of the EndoZip in the treatment of obesity.
- Trial name
- NCT03472196
- Testing
- EndoZip System
- Where
- Spain
- Volunteers
- 14 people
- Sponsor
- Nitinotes Surgical Ltd.
Atrial Fibrillation
Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF
The study is intended to assess the safety and performance of the Vado™ Steerable Sheath in facilitating ease of access to the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation and persistent atrial…
- Trial name
- NCT02521896
- Testing
- Steerable Sheath System
- Volunteers
- 8 people
- Sponsor
- Kalila Medical
Black Triangles Syndrome (BTS), Periodontal Gingival Contraction
Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS)
The treatment of black triangles in modern dentistry involves various approaches, both surgical and nonsurgical. Surgical methods aim to reconstruct or preserve gingival tissue using techniques such as soft tissue flaps or…
- Trial name
- NCT07185191
- Testing
- RDM36, Saline Solution (NaCl 0,9%)
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Mastelli S.r.l
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