Clinical trials: Safety and Performance
Injections, Intradermal
Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.
The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery devices can safely and precisely inject liquid into the intradermal layer of the skin in three different injection locations
- Trial name
- NCT01943110
- Testing
- ID adapter (autodisable), ID adapter (side load)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- PATH
Large Hole Percutaneous Venous Closure
PerQseal® Elite Venous Clinical Study (ELITE-Venous)
The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F)…
- Trial name
- ELITE-Venous (NCT06007339)
- Testing
- PerQseal ELITE
- Where
- Netherlands
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited
Anesthesia
Modified Paramedian Versus Conventional Technique in the Residency Training: An Observational Study
Residency training includes positive and negative aspects. Well-trained doctors must be educated, but the process may bring additional risks to patients.
- Trial name
- NCT03389672
- Testing
- spinal anesthesia, epidural anesthesia, combined spinal-epidural anesthesia
- Volunteers
- 518 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Healthy Volunteers
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars
- Trial name
- NCT03127384
- Testing
- Restylane Lidocaine, No-treatment control
- Where
- 2 sites in Germany
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Over Active Bladder
BlueWind Medical System for the Treatment of Patients With OAB
BlueWind system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)
- Trial name
- OAB (NCT02299544)
- Testing
- BlueWind Medical system
- Where
- 6 sites in Netherlands, United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- BlueWind Medical
Aging Problems
Safety and Performance of DKL Crosslinked Sodium Hyaluronate 26 Dermal Filler for Cheek Augmentation
This is a pivotal, prospective, active-controlled, randomized, double blinded (blinded evaluator and subject), intra-individual split-face comparison, non-inferiority study of DKL crosslinked sodium hyaluronate 26 versus Juvederm…
- Trial name
- NCT05021926
- Testing
- DKL crosslinked sodium hyaluronate 26, Juvéderm Voluma™ with lidocaine (Allergan, Inc)
- Where
- Sweden
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Korman Laboratories Ltd.
Correction of Nasolabial Folds
A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds
A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.
- Trial name
- NCT05106751
- Testing
- Hyaluronic acid dermal filler
- Where
- Germany
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- LG Chem
Breast Cancer
HydroMARK Post-market Clinical Follow-up Study
The purpose of this study is to assess the safety and performance of the HydroMARK Breast Biopsy Site Marker manufactured in the Devicor Medical Products, Inc. Tijuana facility.
- Trial name
- NCT04622696
- Testing
- Ultrasound imaging
- Where
- 3 sites in United States
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- Devicor Medical Products, Inc.
Heart Failure，Congestive
Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure.
- Trial name
- NCT03751904
- Testing
- AcoustiCare
- Volunteers
- healthy volunteers welcome
- Sponsor
- Signature Medical, Inc.
Correction of Nasolabial Folds
A Clinical Investigation of the Decoria® Aesthetic Group (DAG) for Correction of Nasolabial Folds (NLF)
Decoria intense is a class III medical device and is CE-marked and has been on the market since 2014. Decoria intense is a hyaluronic acid filler that will be used according to intended use for correction of nasolabial folds.
- Trial name
- Decorate01 (NCT05235126)
- Testing
- Decoria intense
- Where
- 2 sites in Sweden
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Bohus Biotech AB
Fatigue, Anesthesia
Effect of Fatigue on Regional Anaesthesia Task
The adverse effects of sleep related fatigue are significant, impacting on doctors' health, wellbeing, performance and ultimately their safety and that of their patients'.
- Trial name
- NCT04711499
- Testing
- Fatigue
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Nottingham University Hospitals NHS Trust
Glaucoma, Ocular Hypertension
This Follow-up Extension Study is Aimed to Monitor the Long-term IOP-lowering Performance/Efficacy and Safety of the MINT® Procedure in Open Angle Glaucoma Eyes.
This follow-up extension study is planned to invite all patients who underwent the MINT® surgery and completed Month 24 Visit in the prior MMS EEU-7 study.
- Conditions
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
- Trial name
- NCT07081347
- Testing
- MINT Minimally Invasive Nasal Trabeculostomy
- Where
- Armenia
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Sanoculis Ltd
Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus
Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty
Evaluation of the performance and safety of the Catalyst CSR Shoulder System with clinical and radiographic results at multiple time points through 24 months postoperatively This study will be a prospective multi-center study…
- Conditions
- Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus, Rheumatoid Arthritis Shoulder
- Trial name
- NCT04968405
- Testing
- Catalyst CSR Total Shoulder System
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Catalyst OrthoScience
Healthy
A First-in-human Trial to Assess the Safety and Performance of the BioCaptis in Healthy Volunteers
Liquid biopsy is a new field in medicine where doctors can look at small molecules in our blood, called DNA, that carry the genetic material that makes us who we are.
- Trial name
- NCT05813041
- Testing
- BioCaptis
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- BioCaptiva Ltd.
Overtraining Syndrome
Safety and Prevention of OveRTraining
Athletic training aims to increase and improve physical performance that is achieved through training overload combined with periods of rest and recovery.
- Trial name
- SuPpOrt (NCT03833973)
- Testing
- Overtraining Monitoring
- Where
- Greece
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Thessaly
Lower Limb Ulcers
VergenixTM Flowable Gel in Patients With Lower Limb Ulcers
Vergenix Flowable Gel is indicated for the management of acute and chronic wounds
- Trial name
- CP-FG-001 (NCT02598180)
- Testing
- VergenixTM Flowable Gel
- Where
- 4 sites in Israel
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Collplant
Cognition, Stress Reaction
rTMS to Enhance Cognitive Performance and Promote Resilience
The purpose of this study is to determine the most effective dose of brief, non-invasive brain stimulation (repetitive transcranial magnetic stimulation, rTMS) for improving cognitive functions such as attention and memory as…
- Trial name
- NCT04123496
- Testing
- rTMS
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Cellulite
Profound Dermal and SubQ Cartridges for the Treatment of Cellulite
Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.
- Trial name
- NCT03078647
- Testing
- Profound
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Syneron Medical
Haemofiltration
Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System
This is a single centre, prospective, non-randomised healthy volunteer study to be undertaken at University College Hospital London.
- Trial name
- NCT03786536
- Testing
- MediSieve Magnetic Haemofiltration System
- Volunteers
- healthy volunteers welcome
- Sponsor
- MediSieve Limited
Healthy Participants, Healthy Population
Evaluate the Safety and Feasibility of tACS With the Miamind Neurostimulator in Healthy Participants
The present study aims to assess the safety and feasibility of repeated transcranial alternating current stimulation (tACS) by the Miamind Neurostimulator in a cohort of healthy participants.
- Trial name
- MindStim (NCT05999916)
- Testing
- Personalized Miamind Neurostimulator
- Where
- Switzerland
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Bottneuro AG