Clinical trials: Safety and Performance
Common Warts, Plantar Warts
Salicylic Acid Wart Patch for the Treatment of Common Warts and Plantar Warts
Common and plantar warts are a type of skin lesion caused by infection with the human papilloma virus. The incidence of warts is relatively high, with an estimated few to several per cent of the adult population affected.
- Trial name
- NCT06958237
- Testing
- salicylic acid wart patches
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Langsteiner sp. z o.o.
Oral Bone Defect, Maxillofacial Bone Defect
Performance and Safety of the Resorbable Collagen Membrane "Ez Cure"
The evaluation of the clinical data has demonstrated the conformity of the Resorbable Collagen Membrane (RCM), EZ CureTM, with the relevant essential requirements for its use in periodontal applications.
- Conditions
- Oral Bone Defect, Maxillofacial Bone Defect, Periodontal Bone Loss, Alveolar Bone Loss
- Trial name
- NCT03978962
- Testing
- Guided Tissue Regeneration
- Where
- 2 sites in France
- Volunteers
- 56 people
- Sponsor
- Biomatlante
Coronary Artery Disease, Coronary Artery Stenosis
First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)
BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).
- Trial name
- BIOSOLVE-II (NCT01960504)
- Testing
- Percutaneous Coronary Intervention (DREAMS) stenting
- Where
- 13 sites in Belgium, Brazil and 6 more
- Volunteers
- 123 people
- Sponsor
- Biotronik AG
Aneurysm Cerebral
Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms
To assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, wide-neck or fusiform intracranial aneurysms located on the internal carotid artery (ICA) or its branches
- Trial name
- NV01 (NCT07079956)
- Testing
- TUBE Flow Diverter
- Where
- 3 sites in Brazil
- Volunteers
- 20 people
- Sponsor
- NVMedTech
Dermatitis
Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam
The scope of this open label clinical trial is to evaluate and confirm the performance of DermoRelizema ecofoam in the improvement of the dermatitis severity, by alleviating the symptomatology.
- Trial name
- NCT04826471
- Testing
- DermoRelizema ecofoam
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Relife S.r.l.
Knee Injuries and Disorders, Shoulder Disease
C Scope Visualization System Prospective Study
Evaluation of the performance and safety of the C Scope Visualization System
- Conditions
- Knee Injuries and Disorders, Shoulder Disease, Shoulder Injuries
- Trial name
- NCT05153863
- Testing
- C Scope Visualization System
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- CIT Ortho
Venous System, Venous Access
A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports
This study is a retrospective, observational, monocenter case series. The purpose of this study is to collect clinical data to describe the use of POLYSITE® and SEESITE® devices and verify overall safety and performance.
- Conditions
- Venous System, Venous Access, Chemotherapy, Antibiotics
- Trial name
- NCT05519787
- Testing
- Central Veinous access devices' insertion
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Perouse Medical
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
Myoma
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove…
- Trial name
- NCT00562471
- Testing
- Adhibit Adhesion Prevention Gel, Standard of Care Comparator
- Where
- 6 sites in Canada, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- Angiotech Pharmaceuticals
Knee Osteoarthristis
New Treatment of Knee Osteoarthritis
Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint marginal osteophyte formation and…
- Trial name
- PIVHAC (NCT06611098)
- Testing
- Viscosupplements
- Where
- 2 sites in Georgia, Latvia
- Volunteers
- 134 people
- Sponsor
- Symatese
Cataract, Vitrectomy
Clinical Study to Confirm the Safety and Performance of the Virtuoso Phaco-vitrectomy Device
This is a pre-market clinical investigation with a device that does not bear the CE-marking. Aim of the study is to confirm the safety and performance of the device and collect user feedback.
- Conditions
- Cataract, Vitrectomy, Vitrectomy Operation Under General Anesthesia
- Trial name
- Virtuoso1 (NCT06799156)
- Where
- Germany
- Volunteers
- 205 people
- Sponsor
- Beaver-Visitec International, Inc.
Ventral Hernia
AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair
Medtronic is sponsoring and funding the AFFIX study, a prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study.
- Trial name
- AFFIX (NCT06710795)
- Testing
- MaxTack™ Motorized Fixation Device
- Where
- 3 sites in United States
- Volunteers
- 35 people
- Sponsor
- Medtronic - MITG
Skull Fractures
PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
The CranioFix®2 PMCF study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer.
- Trial name
- CRANFLAP (NCT05119595)
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Aesculap AG
To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.
- Trial name
- NCT02036177
- Testing
- SCu300A IUB intrauterine device, T380A IUD
- Where
- 2 sites in Bulgaria, Romania
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
Transcatheter Aortic Valve Implantation
Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System. The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months.
- Trial name
- EMPIRE-II (NCT05804903)
- Testing
- (ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 7 sites in Finland, Germany and 3 more
- Volunteers
- 177 people
- Sponsor
- NVT GmbH
Fractures of the Long Bones, Vertically Stable Pelvic Fractures
Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY Study
The GALAXY FIXATIONTM System and Orthofix implantable devices study intends to evaluate the clinical performance and safety profile of the study medical/investigational devices in the standard clinical practice.
- Conditions
- Fractures of the Long Bones, Vertically Stable Pelvic Fractures, Vertically Unstable Pelvic Fractures
- Trial name
- NCT06690437
- Testing
- Galaxy Fixation System and Orthofix implantable devices
- Where
- 3 sites in Italy
- Volunteers
- 3 people
- Sponsor
- Orthofix s.r.l.
Facial Aging, Skin Rejuvenation
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
The aim of the study is to verify safety and performance of Semical dermal fillers according to real-world data.
- Conditions
- Facial Aging, Skin Rejuvenation, Volume Defects in the Mid-face, Lip Augmentation and Correction of Perioral Rhytids
- Trial name
- SEMDERMA (NCT07160777)
- Testing
- cross-linked hyaluronic acid, Mesolifter
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Semikal Technology
Cartilage Diseases
Non-interventional Study With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee With MAC
Retrospective, multicenter, single arm, non-interventional study to assess the safety and Performance of NOVOCART Basic and the clinical outcome of MAC with NOVOCART Basic in patients treated for cartilage defects in the knee.
- Trial name
- NBasic (NCT03808623)
- Testing
- MAC with NOVOCART Basic
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 41 people
- Sponsor
- Tetec AG
Solid Tumor
A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors
This Phase I/II clinical study, titled "A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors", aims to evaluate the safety and diagnostic performance of F18 FBPA PET/CT imaging in…
- Trial name
- NCT07691775
- Testing
- F18 FBPA Injection
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Heron Neutron Medical Corp.
Prostate Cancer (Diagnosis)
Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
The investigators are imaging patients with newly diagnosed prostate cancer using a new Positron Emission Tomography (PET) imaging agent (68Ga-NYM032) in order to evaluate the safety and diagnostic performance.
- Trial name
- NCT07615101
- Testing
- 68-Ga-NYM032
- Where
- 2 sites in China
- Volunteers
- 365 people
- Sponsor
- Norroy Bioscience Co., LTD
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