Clinical trials: Safety and Performance
- Condition Safety and Performance
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Meniscus Tear
Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations
This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair…
- Trial name
- FAST-FIX FLEX (NCT04903106)
- Testing
- FAST-FIX FLEX Meniscal Repair System
- Where
- 5 sites in United States, Australia and 2 more
- Volunteers
- 63 people
- Sponsor
- Smith & Nephew, Inc.
Attention Deficit/Hyperactivity Disorder (ADHD)
The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
The primary objective of this trial is to determine whether an oral administration of Phosphatidylserine-Omega3 would significantly improve the clinical symptoms of children suffering from ADHD.
- Trial name
- NCT00418184
- Testing
- Phosphatidylserine-Omega3, Colored cellulose tainted with fishy odor
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Enzymotec
Dry Eye Disease
Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease
The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).
- Trial name
- NCT06444516
- Testing
- FID123300 ocular lubricant
- Where
- 9 sites in United States
- Volunteers
- 188 people
- Sponsor
- Alcon Research
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
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Glaucoma, Open Angle Glaucoma
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
- Trial name
- NCT04773106
- Testing
- ARGOS-SC suprachoroidal pressure sensor
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 22 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Stroke, Parkinson Disease
Videofluoroscopic Swallowing Study (VFSS)
The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.
- Conditions
- Stroke, Parkinson Disease, Multiple Sclerosis, Oropharyngeal Dysphagia
- Trial name
- PORSCHE (NCT03387267)
- Testing
- Dysphagia Detection System
- Where
- 13 sites in United States, Finland
- Volunteers
- 452 people
- Sponsor
- Société des Produits Nestlé (SPN)
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
Cochlear Hearing Loss
Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is…
- Trial name
- NCT04929470
- Testing
- cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 37 people
- Sponsor
- Advanced Bionics AG
Keratoconus
Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.
- Trial name
- NCT02979054
- Testing
- T4020
- Where
- 4 sites in Bulgaria, France and 2 more
- Volunteers
- 157 people
- Sponsor
- Laboratoires Thea
Glaucoma
Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with…
- Trial name
- NCT03868254
- Testing
- XEN Group, Phacoemulsification
- Where
- United States
- Volunteers
- 174 people
- Sponsor
- Allergan
Acne, Scars
Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.
The scope of this open label clinical trial is to evaluate and confirm the performance of Papix acne scar in the prevention and improvement of acne scars in subject suffering for mild to moderate acne.
- Trial name
- NCT04806594
- Testing
- Papix acne scar
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Relife S.r.l.
Osteoarthritis, Rheumatoid Arthritis
Exceed ABT Acetabular Cup Cementless System
A Post-market Clinical Follow-up Study to provide safety, performance and clinical benefits data on the Exceed ABT acetabular cup (implants and instruments) when used in combination with ceramic liners or polyethylene…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Correction of Functional Deformity
- Trial name
- NCT04255394
- Volunteers
- 677 people
- Sponsor
- Zimmer Biomet
Retention, Urinary
Investigation of New Intermittent Catheters in Healthy Volunteers
Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
- Trial name
- NCT04445051
- Testing
- SpeediCath® Standard male or female, New intermittent Variant 1 catheter for male or female, New intermittent Variant 2 catheter for male or female
- Where
- Denmark
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Intracranial Aneurysm
Coil Assisted Flow Diversion Safety and Performance Study
Cerus Endovascular is sponsoring a prospective, single arm, multi-center study to document the safety and performance of Neqstent in adjunctive therapy.
- Trial name
- CAFI (NCT04187573)
- Testing
- Neqstent
- Where
- 7 sites in Austria, Canada and 3 more
- Volunteers
- 38 people
- Sponsor
- Cerus Endovascular, Inc.
Diabetic Foot Ulcers
Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU).
- Trial name
- CHEXU 01 (NCT02091778)
- Testing
- Fast gelling dressing
- Where
- 2 sites in United Kingdom
- Volunteers
- 21 people
- Sponsor
- Molnlycke Health Care AB
Cataract
Cataract Surgery: Femto LDV Z8 Versus Conventional
The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract…
- Trial name
- COMFORT (NCT02351271)
- Testing
- Femto LDV Z8, Manual capsulorhexis&lens fragmentation
- Volunteers
- 130 people
- Sponsor
- Ziemer Ophthalmic Systems AG
Percutaneous Closure of Arteriotomy in Common Femoral Artery
Safety and Performance Study of Large Hole Vascular Closure Device
The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture…
- Trial name
- FRONTIER-I (NCT01943344)
- Testing
- VIVASURE CLOSURE DEVICE™
- Where
- Ireland
- Volunteers
- 12 people
- Sponsor
- Vivasure Medical Limited
Ileostomy - Stoma
Investigation of the Performance of Ostomy Base Plate
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2.
- Trial name
- NCT01103466
- Testing
- Atlas, SenSura, Conform 2
- Where
- Denmark
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children
Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).
- Trial name
- PUL (NCT02106351)
- Testing
- Botulinum toxin type A
- Where
- 31 sites in United States, Belgium and 6 more
- Volunteers
- 212 people
- Sponsor
- Ipsen