Clinical trials: Safety and Performance
Skin Hydration, Skin Elasticity
Efficacy and Safety of PN+HA (NEWEST) for the Improvement of Skin Hydration
This is a post-market, monocentric, interventional, single-arm, confirmative clinical investigation to evaluate the performance and the safety of PN+HA (NEWEST) for the improvement of skin hydration.
- Trial name
- NCT06821867
- Testing
- PN + HA (Newest)
- Where
- Italy
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Mastelli S.r.l
Heart Failure
A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System
The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.
- Trial name
- NCT06147336
- Testing
- V-LAP™ SYSTEM
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Vectorious Medical Technologies Ltd.
Benign Prostatic Hyperplasia
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
The purpose of this study is to evaluate the safety and performance of the ProstaCare System in relieving symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia.
- Trial name
- NCT02962674
- Testing
- prostaFix System
- Where
- 3 sites in New Zealand, Singapore
- Volunteers
- 49 people
- Sponsor
- ProstaCare Singapore Pte. Ltd.
Full Thickness Rotator Cuff Tear
Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears.
- Trial name
- NCT01256242
- Testing
- Augment Rotator Cuff, Standard Suture Repair
- Where
- 4 sites in Canada
- Volunteers
- 31 people
- Sponsor
- BioMimetic Therapeutics
Peripheral Arterial Disease
POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling
The POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects.
- Trial name
- POWER-PAD-1 (NCT05192473)
- Testing
- Pulse Intravascular Lithotripsy System
- Where
- 3 sites in Australia, Dominican Republic and 1 more
- Volunteers
- 9 people
- Sponsor
- Amplitude Vascular Systems, Inc.
Wound
Post Market Surveillance Study to Confirm Safety and Performance of Silicone PHMB Foam
Post market surveillance study to confirm the safety and performance of Silicone Subcategory of PHMB Foam Dressings in Chronic and Acute Wounds.
- Trial name
- NCT04621825
- Testing
- ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.
- Where
- 3 sites in South Africa
- Volunteers
- 187 people
- Sponsor
- Advanced Medical Solutions Ltd.
Coronary Artery Disease
First in Men Study: BIOMAG-I
A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.
- Trial name
- NCT04157153
- Testing
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Where
- 14 sites in Austria, Belgium and 6 more
- Volunteers
- 116 people
- Sponsor
- Biotronik AG
Social Anxiety Disorder
Feasibility Study of PH94B Nasal Spray for Acute Treatment of Social Anxiety Disorder (SAD)
The purpose of the study is to determine whether the PH94B nasal spray is effective for Acute Treatment of the symptoms of Social Anxiety Disorder (SAD) in adult men and women.
- Trial name
- NCT02622958
- Testing
- PH94B
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Pherin Pharmaceuticals, Inc.
Osteoarthritis, Knee, Rheumatoid Arthritis of Knee
Evaluation of The Safety And Performance of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
Prospective, multi-centre, non-comparative, post-market surveillance clinical study
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Traumatic Arthritis of Knee (Diagnosis), Polyarthritis
- Trial name
- NCT03224689
- Testing
- PEEK-Optima Femoral Component
- Where
- Belgium
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Maxx Orthopedics Inc
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Atrial Fibrillation, Tachycardia, Supraventricular
TOCCATA - Touch+™ for Catheter Ablation
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation.
- Trial name
- TOCCATA (NCT01223469)
- Testing
- Contact force assisted irrigated RF ablation
- Volunteers
- 77 people
- Sponsor
- Abbott Medical Devices
Fractures, Bone
Retrospective Study on Clinical Performance and Safety Profile of MJ-Flex Elastic Nail
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the MJ-FLEX elastic nail used in pediatric patients according to the manufacturer Instructions For Use…
- Trial name
- MJ-Flex (NCT06412913)
- Testing
- MJ-Flex The New Metaizeau Nail
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Orthofix s.r.l.
Chronic Total Occlusion of Coronary Artery, Coronary Occlusion
ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to: Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT01759290
- Testing
- Absorb Bioresorbable Vascular Scaffold
- Where
- Belgium
- Volunteers
- 1,800 people
- Sponsor
- Abbott Medical Devices
Benign ProstaticHyperplasia (BPH)
Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
The ProArc Medical ClearRing™ system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH.
- Trial name
- NCT02639442
- Testing
- ClearRing™
- Where
- 2 sites in Israel, Latvia
- Volunteers
- 29 people
- Sponsor
- ProArc Medical
Malignant Wounds
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds
This is a prospective, open, non-controlled clinical investigation to evaluate the performance and safety of using Mepilex Transfer Ag on a malignant wound.
- Trial name
- NCT02431741
- Testing
- Mepilex Transfer Ag
- Where
- 2 sites in Czechia
- Volunteers
- 14 people
- Sponsor
- Molnlycke Health Care AB
Haemorrhoidal Disease
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of PROCTOeze® PLUS
This trial aims to evaluate the overall performance and safety of the MD PROCTOeze® PLUS in relieving symptomatology of haemorrhoidal disease and anal irritation in adult patients affected by Grade I-II (Goligher classification)…
- Trial name
- NCT06944951
- Testing
- Hydrophilic emulsion for the relief of haemorroidal symptoms
- Where
- Romania
- Volunteers
- 50 people
- Sponsor
- Biokosmes Srl
Oral Hemorrhage
Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental…
- Trial name
- NCT05171231
- Testing
- HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD
- Where
- 10 sites in Belgium, France
- Volunteers
- 125 people
- Sponsor
- Septodont
Surgery, Orthognathic Surgery
Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.
- Conditions
- Surgery, Orthognathic Surgery, Orthognathic Surgical Procedures
- Trial name
- NCT05073757
- Testing
- Custom-made guides and plates
- Where
- 4 sites in Belgium, France
- Volunteers
- 56 people
- Sponsor
- Global D
Tendon Injuries
Adaprev in Digital Flexor Tendon Repair
This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function…
- Trial name
- NCT01014494
- Testing
- Adaprev
- Where
- 9 sites in United Kingdom
- Volunteers
- 44 people
- Sponsor
- Renovo
Urinary Incontinence, Fecal Incontinence
Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)
This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number…
- Conditions
- Urinary Incontinence, Fecal Incontinence, Urge Incontinence, Nocturia
- Trial name
- NCT05368246
- Testing
- UCon
- Where
- 3 sites in Denmark
- Volunteers
- 80 people
- Sponsor
- InnoCon Medical
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