Clinical trials: Safety and Performance
Tumor, Cerebral Ventricle, Tumor, Cerebellar
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
- Conditions
- Tumor, Cerebral Ventricle, Tumor, Cerebellar, Aneurysm Cerebral, Trauma, Brain
- Trial name
- LYOPLACE (NCT05441618)
- Testing
- Lyoplant®
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Aesculap AG
Intracranial Artery Stenosis
Efficacy and Safety of a New Balloon Microcatheter in the Treatment of Intracranial Artery Stenosis
The primary objective of this trial is to evaluate the safety and efficacy of a new balloon microcatheter in patients with intracranial artery stenosis.
- Trial name
- NCT07170618
- Testing
- balloon microcatheter
- Where
- China
- Volunteers
- 56 people
- Sponsor
- Sinomed Neurovita Technology Inc.
Patellofemoral Pain Syndrome, Patellar Instability
Assessment of the Safety and Performance of a Patellofemoral Brace
Decathlon has developed kneeSOFT500 product, which is a medical device intended to be used on the knee to keep a physical activity on a regular basis in case of patellofemoral pain syndrome or patellar instability.
- Trial name
- NCT04653753
- Testing
- kneeSOFT500
- Where
- 4 sites in France
- Volunteers
- 30 people
- Sponsor
- Decathlon SE
Exercise, Blood Pressure
Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise Performance
Examining the safety and tolerability of Lentil Protein Hydrolysate in healthy males and females whilst exploring the effects of a dose range on blood pressure control and vascular function and exercise performance
- Conditions
- Exercise, Blood Pressure, Vasodilation, Vascular Function in Healthy Volunteers
- Trial name
- NCT06894875
- Testing
- Lentil protein hydrolysate
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Nuritas Ltd
Acute Migraine
PBASE-system Acute Migraine Clinical Investigation
To evaluate the performance and safety of the PBASE-system when used in the treatment of acute migraine episodes of moderate to severe intensity.
- Trial name
- NCT01680029
- Testing
- PBASE-system 2.0
- Where
- 3 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Chordate Medical
Aging, Aesthetic
Clinical Performance and Safety of STYLAGE® HydroMax
FHAME is a post-market clinical investigation designed to strengthen the clinical evidence supporting the effectiveness of STYLAGE® HydroMax in the treatment of superficial wrinkles, primarily on the cheeks.
- Trial name
- FHAME (NCT07153237)
- Testing
- STYLAGE® HydroMax
- Where
- 2 sites in France
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Laboratoires Vivacy
Pain; Bone Neoplasms; Neoplasm Metastasis
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain.
- Trial name
- NCT02561039
- Testing
- Ibandronate
- Where
- 9 sites in Bulgaria
- Volunteers
- 97 people
- Sponsor
- Hoffmann-La Roche
Vascular Access Device
A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
The objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality data on the performance, safety, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting
- Trial name
- VADER (NCT06604039)
- Testing
- Central venous catheter
- Where
- 3 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Teleflex
Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.
- Conditions
- Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- MINITAC (NCT04186481)
- Testing
- MINITAC Ti 2.0 suture anchor
- Where
- Australia
- Volunteers
- 32 people
- Sponsor
- Smith & Nephew, Inc.
Atrial Septal Defect, Patent Foramen Ovale
Post Market Registry of the CBSO
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD)…
- Trial name
- CBSO Registry (NCT04105595)
- Testing
- Septal defect closure
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- atHeart Medical
Hyperpronated Foot, Reconstruction Surgeries of the Foot
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of…
- Conditions
- Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle
- Trial name
- NCT04715139
- Testing
- Products listed in Group/Cohort Description
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Arthrex, Inc.
Sjogren Syndrome
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Treatment Method for Sjogren's Syndrome (SS)
The purpose of the study is to investigate the effect and safety of the Walther System delivering INMEST (intranasal mechanical stimulation) on people with Sjogren\'s syndrome.
- Trial name
- A-SS-001 (NCT06626477)
- Testing
- Intra nasal mechanical stimulation treatment (INMEST)
- Where
- Sweden
- Volunteers
- 26 people
- Sponsor
- Abilion Medical Systems AB
Dental Implant, Dental Restoration
Performance and Safety Use of the Nanostructured Titanium Dental Implant "KONTACT N"
A multicenter prospective observational study in which aim is to illustrate the clinical outcome of dental implants "Kontact N"; and the effects of its nanostructured surface on the osseointegration and secondary stability…
- Conditions
- Dental Implant, Dental Restoration, Edentulous Alveolar Ridge, Implant-supported Fixed Prosthesis
- Trial name
- NCT03582657
- Testing
- dental implant (KONTACT N)
- Where
- France
- Volunteers
- 164 people
- Sponsor
- Biotech Dental
18 to 24 F Percutaneous Femoral Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device
The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral…
- Trial name
- Frontier-III (NCT02788448)
- Testing
- VIVASURE CLOSURE DEVICE
- Where
- 3 sites in Germany
- Volunteers
- 42 people
- Sponsor
- Vivasure Medical Limited
Wound Healing Disorder
Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds
The primary objective of the study is to evaluate the safety and performance of a Class IIB medical device based on linear hyaluronic acid used in the treatment of post-surgical wounds.
- Trial name
- WOUND-H (NCT06284538)
- Testing
- NOVA.EMOSTOP RE-EPITHELIZING
- Where
- Italy
- Volunteers
- 112 people
- Sponsor
- Nova Argentia S.r.l.
Atopic Dermatitis
URGO FilmoCream Eczema + Dermocorticoids in Atopic Dermatitis
The goal of this clinical study is to determine whether URGO FilmoCream Eczema is effective as a non-steroidal treatment to relieve symptoms of atopic dermatitis.
- Trial name
- GERONIMO (NCT07295678)
- Testing
- Treatment period with dermocorticoid alone, Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid, Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid
- Where
- 2 sites in Poland
- Volunteers
- 44 people
- Sponsor
- CEN Biotech
Breast Implant Revision, Breast Augmentation Complications
Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery
The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation…
- Conditions
- Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
- Trial name
- NCT07367698
- Testing
- Implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- 3 sites in Australia
- Volunteers
- 87 people
- Sponsor
- BellaSeno Pty Ltd
Acute Decompensated Heart Failure
Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.
- Trial name
- NCT05759806
- Testing
- Nephronyx system (Perfuser)
- Where
- 4 sites in Israel
- Volunteers
- 10 people
- Sponsor
- Nephronyx LTD
Dental Implants
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety in the medium and long term of implant-prosthetic systems including…
- Trial name
- NCT04960904
- Testing
- Dental implant surgery with implants
- Where
- 2 sites in France, Greece
- Volunteers
- 514 people
- Sponsor
- Global D
Meniscus Tear
Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations
This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair…
- Trial name
- FAST-FIX FLEX (NCT04903106)
- Testing
- FAST-FIX FLEX Meniscal Repair System
- Where
- 5 sites in United States, Australia and 2 more
- Volunteers
- 63 people
- Sponsor
- Smith & Nephew, Inc.
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