Clinical trials: Performance and Safety
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
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
Ileostomy - Stoma
Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy
Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.
- Trial name
- NCT03416023
- Testing
- TIES® (Transcutaneous Implant Evacuation System)
- Where
- 4 sites in Sweden, United Kingdom
- Volunteers
- 28 people
- Sponsor
- Ostomycure AB
Diaphragm Pacing
Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures
Feasibility study to advance the development of NeuRx Diaphragm Pacing System (DPS) for the intended use of stimulating the diaphragm to provide respiratory assistance in patients at risk of prolonged mechanical ventilation in…
- Trial name
- NCT02410798
- Testing
- TransLoc electrode
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Synapse Biomedical
Primary Open Angle Glaucoma (POAG)
Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)
The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients with POAG and indicated cataract surgery.
- Trial name
- NCT02434692
- Testing
- ARGOS-IO system
- Where
- 11 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Ileostomy - Stoma
Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
- Trial name
- NCT01799239
- Testing
- Test product, SenSura
- Where
- Sweden
- Volunteers
- 32 people
- Sponsor
- Coloplast A/S
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.
Teeth Straightening, Aligner Therapy
A Study to Compare Nighttime Aligners to Daytime Aligners
The purpose of this research study is to see if Nighttime Aligners (worn 10-12 hours per day or night) are effective and safe for tooth movement and if so, how they compare with the standard Daytime aligners (worn 20-22 hours per…
- Conditions
- Teeth Straightening, Aligner Therapy, Orthodontic Aligner
- Trial name
- NCT06539676
- Testing
- Nighttime Aligners, Daytime Aligners
- Where
- 12 sites in United States
- Volunteers
- 7 people
- Sponsor
- Dentsply Sirona Implants and Consumables
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
Carotid Artery Diseases, Stroke
Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with…
- Trial name
- WISE (NCT01783639)
- Testing
- Carotid Artery Stent
- Where
- 10 sites in Belgium, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- Gardia Medical
Peritoneal Carcinomatosis
A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri Mets
Peritoneal carcinomatosis (PC) results from the metastasis of a primary cancer of the peritoneum (e.g., appendiceal, ovarian, uterine, colorectal, and gastric cancers) that then disseminates throughout the abdominal cavity.
- Trial name
- NCT04950166
- Testing
- pegsitacianine
- Where
- 5 sites in United States
- Volunteers
- 51 people
- Sponsor
- OncoNano Medicine, 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
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
Acne Scars - Mixed Atrophic and Hypertrophic
Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of 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
- NCT04827680
- Testing
- Venus Viva MD
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Meniscus Tear, Knee Meniscus Injury
High-Purity Type I Collagen Augmentation in Meniscal Repair
This prospective, single-arm feasibility study evaluates the safety, procedural feasibility, and early clinical outcomes of High-Purity Type I Collagen used as an adjunct in arthroscopic meniscal repair.
- Conditions
- Meniscus Tear, Knee Meniscus Injury, Meniscal Repair, Knee Arthroscopy (for Diagnostic or Therapy)
- Trial name
- NCT07352410
- Testing
- High-Purity Type I Collagen
- Where
- India
- Volunteers
- 18 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Primary Open-angle Glaucoma
Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-IO system in patients with Primary Open Angle Glaucoma (POAG)
- Trial name
- NCT03651336
- Testing
- ARGOS-IO Sensor Pressure System
- Where
- 4 sites in Germany
- Volunteers
- 16 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Dry Eye
Performance and Safety of T2769 in DED
To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment. To evaluate the performance and safety of T2769 versus Vismed® Multi.
- Trial name
- NCT05965778
- Testing
- T2769, Vismed® Multi
- Where
- France
- Volunteers
- 251 people
- Sponsor
- Laboratoires Thea
HSV-2 Infection, Genital Herpes
The VIBLOK SAfety and perFormancE Trial
Genital herpes has a high prevalence in industrialized as well as developing countries. Genital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be transmitted mother to child during birth with…
- Trial name
- SAFE (NCT03080961)
- Testing
- VIBLOK barrier cream
- Where
- 3 sites in Netherlands
- Volunteers
- 82 people
- Sponsor
- CLJI Worldwide
Mitral Valve Regurgitation, Mitral Regurgitation
MitraClip EXPAND G4 Study
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
- Trial name
- NCT04177394
- Testing
- MitraClip G4 System
- Where
- 63 sites in United States, Canada and 8 more
- Volunteers
- 1,164 people
- Sponsor
- Abbott Medical Devices
Breast Cancer
Post Market Study Using the Xoft Axxent System
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
- Trial name
- NCT01017549
- Testing
- Electronic brachytherapy (Axxent System)
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Xoft, Inc.