Clinical trials: Safety and Performance
Mitral Valve Insufficiency
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients.
- Trial name
- NCT02322840
- Testing
- Twelve TMVR Implant, Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
- Where
- 32 sites in United States, Australia and 5 more
- Volunteers
- 128 people
- Sponsor
- Medtronic Cardiovascular
Lung Cancer
First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System
A Prospective, open label, multi center, single arm, First in Human study to assess the safety and initial performance of EAS1 system for Irreversible Electroporation (IRE) ablation of lung cancer in subjects eligible for tumor…
- Trial name
- NCT06423690
- Testing
- EAS1 System
- Where
- 3 sites in Israel, Spain and 1 more
- Volunteers
- 15 people
- Sponsor
- Snipe Medical
Nephrectomy, Prostatectomy
Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP
The purpose of this clinical investigation was to evaluate the safety and performance of the Bitrack System and its corresponding ElectroSurgical Endoscopic (ESE) instruments and Non-ElectroSurgical Endoscopic (NESE) instruments…
- Trial name
- NCT06119568
- Testing
- Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Rob Surgical Systems S.L.
Burns
An Investigation of Performance and Safety of the Wound Dressing FibDex in Patients With Superficial Dermal Burns
This is a prospective, randomised, open-label, within-patient controlled, non-inferiority clinical investigation of the nanofibrillar cellulose (NFC) wound dressing FibDex® for treatment of superficial dermal burns in paediatric…
- Trial name
- NCT05629091
- Testing
- FibDex, Epicite hydro, Epiprotect
- Where
- Sweden
- Volunteers
- 7 people
- Sponsor
- UPM-Kymmene Corporation
Cataract, Presbyopia
Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia
The clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia.
- Conditions
- Cataract, Presbyopia, Hyperopia, Myopia
- Trial name
- NCT05735990
- Testing
- Intraocular lens
- Where
- Spain
- Volunteers
- 21 people
- Sponsor
- Medicontur Medical Engineering Ltd
Total Knee Arthroplasty
Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty
The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral component implanted in the past.
- Trial name
- NCT03720782
- Testing
- LEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral Component
- Where
- 2 sites in United States
- Volunteers
- 118 people
- Sponsor
- Smith & Nephew, Inc.
Adult Intensive Care Patients
GlySure Acute Care Settings Study
The company who have developed the GlySure product have previously carried out a study to be able to show that the GlySure system is accurate in measuring blood sugar (glucose) levels.
- Trial name
- NCT02421107
- Testing
- Glysure CGM, iStat intermittent testing
- Volunteers
- 40 people
- Sponsor
- GlySure
Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid…
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Trial name
- SCOUT-II (NCT03225612)
- Testing
- Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Where
- 11 sites in Germany, Italy and 2 more
- Volunteers
- 60 people
- Sponsor
- Mitralign, Inc.
Healthy Volunteers
SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects
Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126
- Trial name
- NCT05476107
- Testing
- AMT-126, Radioactive Tablet (Part 2 Only)
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Applied Molecular Transport
Breast Augmentation, Breast Reconstruction
Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.
- Trial name
- EMMIE (NCT03386682)
- Testing
- ESTYME® MATRIX Breast Implants
- Where
- 8 sites in France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Symatese Aesthetics
Venous Leg Ulcer, Diabetic Foot Ulcer
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU).
- Trial name
- NCT04817228
- Testing
- EscharEx (EX-02 formulation)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- MediWound Ltd
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
Cervical Disc Disease, Degenerative Disc Disease
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc at two levels in subjects who were enrolled in the IDE study (NCT03123549) and/or…
- Trial name
- NCT05691231
- Testing
- NuVasive Simplify Cervical Artificial Disc
- Where
- 2 sites in United States
- Volunteers
- 158 people
- Sponsor
- NuVasive
Aphakia, Astigmatism
Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
The purpose of this Post-Market Clinical Follow-up study is to describe the long-term safety and performance of the Clareon Vivity and Vivity Toric and Clareon PanOptix and PanOptix Toric IOLs.
- Conditions
- Aphakia, Astigmatism, Presbyopia
- Trial name
- NCT05796453
- Testing
- Clareon Vivity IOL - Non Toric, Clareon Vivity IOL - Toric, Clareon PanOptix Trifocal IOL - Non Toric
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 470 people
- Sponsor
- Alcon Research
Rhytides, Wrinkle
Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
- Trial name
- NCT03831477
- Testing
- Venus Viva
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Peripheral Artery Disease
Safety and Performance of the Zeus CC Stent for the Treatment of Iliac Occlusive Disease
The purpose of this study is to evaluate safety and performance of the balloon-expandable Zeus CC (Rontis AG) stent for the treatment of Trans-Atlantic Inter-Society Consensus (TASC) A, B, C and D iliac lesions.
- Trial name
- EAZY (NCT01499329)
- Where
- Belgium
- Volunteers
- 200 people
- Sponsor
- be Medical
Coronary Artery Stenosis
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family
The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
- Trial name
- NCT05536180
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Arthesys
Vaginitis, Bacterial Vaginosis
Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis
Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora.
- Trial name
- NCT05652959
- Testing
- Cerviron®
- Where
- 10 sites in Romania
- Volunteers
- 111 people
- Sponsor
- Perfect Care Distribution
Tooth Loss, Partially Edentulous Maxilla
Performance and Safety of Use of the "KONTACT PERIO LEVEL" Transgingival Titanium Dental Implant
As part of post-marketing clinical follow-up, BIOTECH DENTAL sets up the collection and evaluation of clinical data proactively with the aim of confirming the safety, performance as well as the constantly acceptable nature of the…
- Conditions
- Tooth Loss, Partially Edentulous Maxilla, Partially Edentulous Mandible
- Trial name
- KPL (NCT05016401)
- Testing
- KONTACT PERIO LEVEL (KPL)
- Where
- France
- Volunteers
- 199 people
- Sponsor
- Biotech Dental
Incision, Surgical, Surgical Incision
A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14…
- Conditions
- Incision, Surgical, Surgical Incision, Surgical Wound, Surgical Wound, Recent
- Trial name
- ASOLO-SCI (NCT04894604)
- Testing
- Avance® Solo NPWT System
- Volunteers
- 34 people
- Sponsor
- Molnlycke Health Care AB
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