Clinical trials: Safety and Performance
Knee Cartilage Lesions
Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Canada
The goal of this First in Human study is to learn if the Nanochon Chondrograft Implant is a safe primary surgical treatment for participants with cartilage lesions in the knee.
- Trial name
- NCT07249489
- Testing
- Nanochon Chondrograft
- Where
- 2 sites in Canada
- Volunteers
- 10 people
- Sponsor
- Nanochon, Inc.
Hypertension Resistant to Conventional Therapy, Bradycardia
Safety and Performance Study of the Moderato System
The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce…
- Conditions
- Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block
- Trial name
- NCT02282033
- Testing
- The Moderato System
- Where
- 10 sites in Austria, Chile and 5 more
- Volunteers
- 57 people
- Sponsor
- BackBeat Medical Inc
Gastroesophageal Reflux Disease (GERD)
Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease
Gastroesophageal Reflux Disease (GERD) is a chronic condition in which stomach acid flows back into the esophagus, causing irritation and inflammation.
- Trial name
- ARMOR (NCT06984484)
- Testing
- Afluxin®
- Where
- 7 sites in Italy
- Volunteers
- 208 people
- Sponsor
- Devintec Sagl
Knee Cartilage Lesions
Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Panama
The goal of this First in Human study is to learn if the Nanochon Chondrograft Implant is a safe primary surgical treatment for participants with cartilage lesions in the knee.
- Trial name
- NCT07542184
- Testing
- Nanochon Chondrograft
- Where
- Panama
- Volunteers
- 5 people
- Sponsor
- Nanochon, Inc.
Pathologic Fracture
Performance and Safety of the Innofix® Screw (IF25)
The purpose of this clinical investigation is to collect data about the safety and the performances of the InnoFix® screw : Clinical performances (Pain reduction due to the fracture treatment, maintenance of the stabilizaton of…
- Trial name
- IF25 (NCT06800417)
- Testing
- Percutaneous fixation by internal cemented screw (InnoFix®)
- Volunteers
- 34 people
- Sponsor
- Innoprod Medical
Heart Failure; With Decompensation, Cardiorenal Syndrome
The Aortix CRS Pilot Study
The Aortix CRS Pilot Study: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome
- Conditions
- Heart Failure; With Decompensation, Cardiorenal Syndrome, Cardio-Renal Syndrome, Heart Failure
- Trial name
- NCT04145635
- Testing
- Aortix System
- Where
- 19 sites in United States, Australia
- Volunteers
- 21 people
- Sponsor
- Procyrion
Cervical Lesion
Clinical Investigation To Evaluate Cerviron Ovules® in Cervix Lesions Postoperative Care
CYRON is a Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron® Ovules in Cervix Lesions Postoperative Care.
- Trial name
- NCT04735718
- Testing
- Cerviron
- Where
- 3 sites in Romania
- Volunteers
- 27 people
- Sponsor
- Perfect Care Distribution
No Condition, Healthy Individuals
Microneedle-based ISF Sampling Technique
This clinical investigation aims to evaluate the performance and safety of the PELSA system, a hollow microneedle-based medical device designed for the collection of dermal interstitial fluid (dISF) from human skin.
- Trial name
- MIST (NCT07882225)
- Testing
- PELSA System
- Where
- Germany
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Ascilion AB
Rotator Cuff Tears, Rotator Cuff Injuries
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study.
- Trial name
- NCT05690776
- Where
- 2 sites in France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
Chronic Heart Failure
Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients
The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.
- Trial name
- NCT04578353
- Testing
- The AquaPass System
- Where
- Israel
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- AquaPass Medical Ltd.
VF, VT
Defibrio AED Study
The purpose of this research is to test an investigational device called the Defibrio AED (automated external defibrillator). The researchers are conducting the study to determine if the Defibrio AED is safe to use and is able to…
- Trial name
- NCT07880873
- Testing
- treatment with Defibrio AED
- Volunteers
- 25 people
- Sponsor
- Defibrio, LLC
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Oncoplastic Breast Surgery, Bilateral Surgery
A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients
The purpose of the study is to assess the use of a wound dressing system called PICO7Y following a two-sided breast surgery. PICO7Y is a new dressing system made to treat two incisions/wounds at the same time, and the purpose of…
- Trial name
- PICO7Y (NCT03835845)
- Testing
- PICO7Y
- Where
- 5 sites in Netherlands, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Benign Prostatic Hyperplasia
The Zenflow Spring System EU Safety and Performance Study
The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
- Trial name
- ZEST EU (NCT03577236)
- Testing
- Zenflow Spring System
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 50 people
- Sponsor
- Zenflow, Inc.
Oxidative Stress, Muscle Strength
The Long-term Effects of Oceanix™ on Resistance Training Adaptations
This study will examine the effects of Oceanix™, an antioxidant supplement, on muscle performance, immune and endocrine function, recovery and safety in participants undergoing resistance training.
- Conditions
- Oxidative Stress, Muscle Strength, Resistance Training, Body Composition
- Trial name
- NCT04136821
- Testing
- Oceanix, Resistance Training
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Applied Science & Performance Institute
Dry Eye, Dry Eye Syndromes
Intra-Nasal Mechanical Stimulation (INMEST) As a Treatment Method for the Relief of Symptoms of Dry Eye
The purpose of the study is to investigate the degree of symptom relief in people with signs or symptoms of dry eyes after self-treatment at home with the Walther System delivering INMEST (intranasal mechanical stimulation).
- Trial name
- NCT05887336
- Testing
- Walther System, Non preserved ocular lubricants, Eye lid procedure
- Where
- 3 sites in Denmark, Sweden
- Volunteers
- 106 people
- Sponsor
- Abilion Medical Systems AB
Gait Impairment, Cerebral Palsy (CP)
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program…
- Conditions
- Gait Impairment, Cerebral Palsy (CP), Neuromuscular Diseases (NMD), Spinal Cord Injuries (SCI)
- Trial name
- NCT07745712
- Testing
- ABLE Kids
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- ABLE Human Motion S.L.
Aortic Stenosis, Aortic Insufficiency
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Trial name
- JUPITER (NCT01598844)
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in Germany, Netherlands and 2 more
- Volunteers
- 210 people
- Sponsor
- JenaValve Technology, Inc.
Bacterial Vaginosis
A Randomised, Partly-blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Bacterial Vaginosis Compared With an Untreated Control Group
This is a randomised, parallel group, partly blinded investigation to evaluate the clinical performance and safety of pHyph in adult women with bacterial vaginosis.
- Trial name
- Nefertiti 2 (NCT06123299)
- Testing
- pHyph
- Where
- 5 sites in Sweden
- Volunteers
- 61 people
- Sponsor
- Gedea Biotech AB
Hemodialysis Access Failure
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
- Trial name
- NCT03734679
- Testing
- SurVeil Drug Coated Balloon
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 12 people
- Sponsor
- SurModics, Inc.
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