Clinical trials: Safety and Performance
Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm
Safety Study of Carotid Body Neurostimulation to Treat Cerebral Vasospasm
The purpose of this study is to evaluate the safety and performance of the Delta system in the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) patients.
- Trial name
- NCT02129413
- Testing
- Delta system
- Where
- 7 sites in Czechia, Germany and 1 more
- Volunteers
- 23 people
- Sponsor
- Samson NeuroSciences
Menorrhagia
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Abnormal uterine bleeding (AUB) is defined as "flow outside of normal volume, duration, regularity, or frequency". Acute AUB is excessive bleeding that requires immediate intervention to prevent further blood loss.
- Trial name
- AQTH-EA-PIV-24 (NCT07877051)
- Testing
- Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)
- Where
- 3 sites in Georgia
- Volunteers
- 43 people
- Sponsor
- Aqua Therapeutics, Inc.
Ankle Arthrodesis or Arthroplasty, Hindfoot Fusion
A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions.
This is a phase IV post-marketing study for MagnetOs Putty and MagnetOs Easypack Putty. MagnetOs is a synthetic bone graft extender product that is routinely used by surgeon as treatment for hindfoot and ankle disorders.
- Conditions
- Ankle Arthrodesis or Arthroplasty, Hindfoot Fusion, Ankle Deformity, Ankle Disease
- Trial name
- ASTRA (NCT07225751)
- Testing
- MagnetOs, Autograft
- Where
- 7 sites in United States
- Volunteers
- 126 people
- Sponsor
- Kuros Biosurgery AG
Mechanically Ventilated Patients
Pilot Clinical Investigation to Evaluate a Prototype of Sensor Measuring Ventilator-derived Parameters
Recently, the threat of viral pandemics (Covid-19, severe acute respiratory syndrome, avian flu H5N1, and H1N1), which might result in thousands of patients requiring mechanical ventilation, has accelerated the need for…
- Trial name
- NCT06054503
- Testing
- prototype of sensor
- Where
- France
- Volunteers
- 59 people
- Sponsor
- Archeon
Dermatitis, Contact, Dermatitis
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters
The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.
- Conditions
- Dermatitis, Contact, Dermatitis, Dermatitis, Chronic, Dermatitis, Eczematous
- Trial name
- NCT07056569
- Testing
- 047_TD Dermatitis cream twice a day for 28 days
- Where
- 3 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Biokosmes Srl
Gonarthrosis
Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
Patients who are to benefit from an injection of SYNOVIUM HCS as part of their care will be offered to participate in this study. Patients will need to sign a consent form to participate.
- Trial name
- YNOVIUM (NCT06087705)
- Testing
- Intra-articular injection of hyaluronic acid
- Where
- France
- Volunteers
- 134 people
- Sponsor
- LCA Pharmaceutical
Removal of Contraceptive Implant
Removal of Palpable Subdermal Contraceptive Rod Implants.
There are no implant removal devices on the market by any manufacturer. New features are described in comparison with the existing removal technique.
- Trial name
- NCT02986971
- Testing
- New IMD
- Where
- Sweden
- Volunteers
- 22 people
- Sponsor
- RemovAid AS
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
Lipodystrophy, Deformities
Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment
The purpose of this post-market clinical follow up study is to assess the safety and performance of Aesthetic Group cannulas. The study will evaluate the outcome of the Aesthetic Group cannulas range over a period of 1 month…
- Trial name
- NCT06089759
- Where
- 3 sites in France
- Volunteers
- 108 people
- Sponsor
- Aesthetic Group
Hearing Loss, Bilateral Sensorineural
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system.
- Trial name
- ELEVATE (NCT07287124)
- Testing
- Cochlear implant
- Where
- 11 sites in United States
- Volunteers
- 56 people
- Sponsor
- Cochlear
Hypertension
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device At Wrist Against Double Auscultation
This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23…
- Trial name
- NCT06565780
- Testing
- Device under test evaluation against references
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Aktiia SA
Bone Augmentation
Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neobone® when used according to its intended purpose and current clinical applications.
- Trial name
- NeoDent01 (NCT07179497)
- Where
- Portugal
- Volunteers
- 66 people
- Sponsor
- Bioceramed
Tibial Fractures, Fracture Infection
Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study
Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation.
- Trial name
- NCT05022485
- Testing
- ZNN Bactiguard tibia
- Where
- 16 sites in Austria, France and 6 more
- Volunteers
- 500 people
- Sponsor
- Zimmer Biomet
Wrinkles Such as Nasolabial Folds
Post Market Study of Safety and Performance of RefillHA Volume+ for Facial Soft Tissue Augmentation and Correction of Wrinkles and Folds
This post market study was designed to collect clinical data regarding the safety and performance of RefillHA Volume+ upon its launch, from patients treated with the product in a routine clinical setting of treatments.
- Trial name
- NCT07109635
- Where
- Israel
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Glyance
Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease
PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella
The study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study.
- Conditions
- Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease, Functional Deformity, Revision Total Knee Arthroplasty
- Trial name
- NCT05253976
- Where
- Switzerland
- Sponsor
- Zimmer Biomet
Urethral Catheter; Complications
Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy
The primary aim of this study is to collect clinical data on the performance of Lubri-cream applied in routine clinical practice.
- Trial name
- NCT06101121
- Testing
- Lubri-Cream
- Volunteers
- 120 people
- Sponsor
- B. Braun Medical SA
Chronic Knee Pain, Chronic Instability of Knee Joint
Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice
Decathlon has developed kneeSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice.
- Trial name
- NCT04601168
- Testing
- kneeSOFT100
- Where
- 2 sites in France
- Volunteers
- 7 people
- Sponsor
- Decathlon SE
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
Sacrocolpopexy
Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted sacrocolpopexy or sacrocervicopexy.
- Trial name
- SPARO (NCT07031050)
- Testing
- sacrocolpopexy or sacrocervicopexy
- Where
- 6 sites in Germany, Switzerland
- Volunteers
- 35 people
- Sponsor
- Distalmotion SA
Wrinkle, Pigmented Lesions
Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™
This study is intended to demonstrate the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles.
- Trial name
- NCT04727099
- Testing
- PicoWay Laser System
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Candela Corporation
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