Clinical trials: Safety and Performance
Sporadic Inclusion Body Myositis
Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic…
- Trial name
- RESILIENT (NCT01925209)
- Testing
- BYM338/bimagrumab
- Where
- 38 sites in United States, Australia and 8 more
- Volunteers
- 251 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Graft vs Host Disease, Congenital Aniridia
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely.
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome
- Trial name
- NCT02945176
- Testing
- ARGOS-IO system
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Ileostomy - Stoma
Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care
To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured
- Trial name
- NCT01957384
- Testing
- Coloplast Test product 1, Coloplast Test product 2, Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Coloplast A/S
Otitis Externa
Performance and Safety of Otinova® Ear Spray
The purpose of this study is to assess the performance and safety of Otinova® Ear Spray when used in the treatment of external otitis symptoms.
- Trial name
- NCT05370209
- Testing
- Otinova® Ear Spray
- Where
- 3 sites in Sweden
- Volunteers
- 28 people
- Sponsor
- Circius Pharma AB
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.
Vaginitis and Vulvovaginitis
Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis
CYRON is a Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron Ovules® in the Local Treatment of Non-Specific or Endogenous, Symptomatic Vaginitis.
- Trial name
- NCT04735705
- Testing
- Cerviron
- Where
- 2 sites in Romania
- Volunteers
- 50 people
- Sponsor
- Perfect Care Distribution
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
Atrial Fibrillation, Atrial Flutter
An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias
- Trial name
- NCT04210622
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- Lithuania
- Volunteers
- 16 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Myopia, Safety Issues
The Safety and Effectiveness of Breath-O Lenses
In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression.
- Trial name
- NCT03616600
- Testing
- Breath-O-Correct Lens
- Where
- Hong Kong
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- The Hong Kong Polytechnic University
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Ileostomy - Stoma
Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece
The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
- Trial name
- NCT01957488
- Testing
- Coloplast Test Product 1, Coloplast Test Product 2, Coloplast SenSura
- Where
- 4 sites in Denmark, Netherlands and 2 more
- Volunteers
- 183 people
- Sponsor
- Coloplast A/S
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Hepatic Disease, Renal Disease
Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following Coaxial Biopsy Procedures
The primary objective for this study is to assess safety and performance of the Kronos Electrocautery Device for electrocautery procedures following coaxial biopsy procedures on areas that include, but are not limited to, liver…
- Trial name
- NCT05593211
- Testing
- Kronos Electrocautery Device
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Single Pass Inc
Hip Arthropathy
Assessment of the Safety and the Performance of the SAGITTA EVL R Stems in Hip Arthroplasties
Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures.
- Trial name
- NCT05153473
- Testing
- Total Hip Arthroplasty Revision
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
Diabetes Mellitus
CareLink Connect - Technical Evaluation Study
The purpose of this study is to evaluate the performance, patient satisfaction and safety of connectivity gateway device CareLink Connect, transferring CGM (Continuous Glucose Monitoring) data from a VEO insulin pump to CareLink…
- Trial name
- NCT01989975
- Where
- 2 sites in Denmark, Netherlands
- Volunteers
- 40 people
- Sponsor
- Medtronic MiniMed, Inc.
Incontinence, Urge
T-DOC® NXT Clinical Investigation
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
- Trial name
- NCT03615001
- Testing
- TDOC NXT
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
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
Aortic Stenosis
DEFLECT I: Keystone Heart Embolic Deflection Trial
This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT01448421
- Testing
- Keystone Heart Embolic Deflection Device
- Volunteers
- 37 people
- Sponsor
- Keystone Heart