Clinical trials: Safety and Performance
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
Symptomatic Femoro-popliteal Chronic Total Occlusion
The Lumen Study: Comparing Devices for Patients With Symptomatic Femoro-popliteal Chronic Total Occlusion (CTO)
This is a prospective, multicenter, randomized, single-blind study enrolling up to 75 subjects at up to 5 sites in the US. Eligible subjects with symptomatic femoro-popliteal CTO will be randomized 2:1 to treatment with the…
- Trial name
- NCT02145299
- Testing
- TruePath CTO Device, CROSSER CTO Device
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Yale University
Venous Leg Ulcer (VLU)
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT02167815
- Testing
- Mepilex XT, standard care
- Where
- 3 sites in Czechia
- Volunteers
- 30 people
- Sponsor
- Molnlycke Health Care AB
Chronic Sinusitis
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.
- Trial name
- S8PK (NCT01894503)
- Testing
- S8 Sinus Implant (mometasone furoate, 1350 mcg)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Intersect ENT
Instability, Joint
Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair
The scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the CE-Mark for this marketed product and to look into safety and efficacy.
- Trial name
- NCT03691298
- Testing
- SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor
- Where
- 9 sites in United States, Denmark and 4 more
- Volunteers
- 83 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Cataract, Corneal Astigmatism
ClarVista HARMONI Toric Trial With Intraoperative Exchange
The purpose of this study was to demonstrate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic in subjects with pre-existing corneal astigmatism in need of cataract surgery.
- Conditions
- Cataract, Corneal Astigmatism, Aphakia
- Trial name
- NCT03054649
- Testing
- HARMONI® Modular Intraocular Lens System, Intraoperative optic exchange
- Where
- 2 sites in Mexico, Philippines
- Volunteers
- 44 people
- Sponsor
- ClarVista Medical
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
Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA.
- Conditions
- Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Correction of Functional Deformity
- Trial name
- NCT03409666
- Testing
- Taperloc Complete Microplasty stem, Taperloc Complete Reduced Distal stem
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet
Cancer, Tumor, Solid
Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X)
The purpose of this study is to assess the performance and safety of Biology-Guided Radiotherapy (BgRT) using the RefleXion Medical Radiotherapy System (RMRS) via optimizing F18-Fluorodeoxyglucose (FDG) dosing, assessing the…
- Conditions
- Cancer, Tumor, Solid, Cancer, Lung, Cancer, Bone
- Trial name
- BIOGUIDE-X (NCT04788147)
- Testing
- RMRS IDE Device
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- RefleXion Medical
Cochlear Hearing Loss
Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiRes Ultra Cl HiFocus MS Electrode and HiRes Ultra 3D Cl HiFocus MS Electrode (Ultra X) under normal conditions of use as it is approved for this…
- Trial name
- NCT04610112
- Testing
- Cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Advanced Bionics AG
Retention, Urinary
Investigation of Non-CE Marked Intermittent Catheters.
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter
- Trial name
- NCT04543136
- Testing
- SpeediCath® Standard male, New intermittent Variant 1 catheter for males, New intermittent Variant 2 catheter for males
- Where
- Denmark
- Volunteers
- 16 people
- Sponsor
- Coloplast A/S
Neurogenic Bladder, Urinary Retention
Connected Catheter - Safety and Effectiveness Study
The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization.
- Conditions
- Neurogenic Bladder, Urinary Retention, Urologic Diseases
- Trial name
- NCT04059159
- Testing
- Connected Catheter
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Spinal Singularity
Wounds
Simplified Negative Pressure Wound Therapy
The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting.
- Trial name
- NCT01339429
- Testing
- simplified negative pressure wound therapy device (Wound Pump device)
- Where
- 2 sites in Rwanda
- Volunteers
- 41 people
- Sponsor
- Brigham and Women's Hospital
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Signs of Facial Aging With Volume Loss in the Upper Cheeks, Nasolabial Folds and Marionette Lines
Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSE® (+) Lidocaine) in the Treatment of Ageing Signs in the Face
The primary objective is to collect clinical data to confirm performance and safety for RADIESSE® (+) Lidocaine, when used in accordance with its labelling in the treatment of nasolabial folds, marionette lines and/or upper cheek…
- Trial name
- RaLido (NCT03650387)
- Testing
- RADIESSE® (+) Lidocaine
- Where
- 7 sites in Germany
- Volunteers
- 207 people
- Sponsor
- Merz North America, Inc.
Aortic Valve Stenosis, Heart Valve Diseases
JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT02732691
- Testing
- JenaValve Pericardial TAVR System
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- JenaValve Technology, Inc.
Acne Scars
Clinical Evaluation of Fractional Radiofrequency for the Treatment Acne Scarring
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring.
- Trial name
- NCT03821324
- Testing
- Venus Viva
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Glaucoma, Open Angle Glaucoma
Performance and Safety of the ARGOS-SC Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery
The purpose of this study is to evaluate both the safety and feasibility of the surgical implantation of the ARGOS-SC implant during non-penetrating glaucoma surgery and the safety and usability of the ARGOS-SC implant and system…
- Trial name
- ARGOS-SC01 (NCT03756662)
- Testing
- ARGOS-SC suprachoroidal pressure sensor
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Implandata Ophthalmic Products GmbH
Sore-throat, Cough
The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study
Demulcent or soothing substance is the currently recommended option to alleviate throat irritation associated to cough and sore throat in children under 6 years.
- Trial name
- Touxpetit (NCT06688370)
- Testing
- Petit Drill
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Pierre Fabre Medicament
Tachyarrhythmias, Heart Failure
Safety and Clinical Performance of the Protecta ICD and CRT-D
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic…
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00982397
- Testing
- Protecta VR-ICD, Protecta DR-ICD or CRT-D
- Where
- 122 sites in United States, Austria and 19 more
- Volunteers
- 2,770 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure