Clinical trials: Safety and Performance
Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree
Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain
Decathlon has developed Ankle STRONG products which are medical devices that must be positioned around the ankle to limit ankle sprain occurrence. The Ankle STRONG devices cover a range of 3 products (Ankle STRONG 100/500/900).
- Conditions
- Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Ankle Sprain 3Rd Degree
- Trial name
- NCT04599829
- Testing
- AnkleSTRONG100/500/900
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Decathlon SE
Lung Cancer
Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK
This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation).
- Trial name
- AB1MALTISC-UK (NCT06869122)
- Testing
- Ablation
- Where
- 2 sites in Italy, United Kingdom
- Volunteers
- 18 people
- Sponsor
- Creo Medical Limited
Hemorrhage, Surgical
Clinical Safety and Performance of GATT-Patch in Open Liver Surgery
The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.
- Trial name
- NCT04819945
- Testing
- GATT-Patch
- Where
- 3 sites in Netherlands
- Volunteers
- 56 people
- Sponsor
- GATT Technologies BV
Nasal Congestion, Nasal Dryness
PMCF Study to Evaluate Performance and Safety of "NASAL SPRAYS " Used to Relieve Nasal Congestion and Dryness
Acute viral upper respiratory tract infection, also known as common cold, is the most frequently observed infectious disease in human beings.
- Trial name
- NCT05843071
- Testing
- Nasal sprays with sea salts
- Where
- Italy
- Volunteers
- 105 people
- Sponsor
- C.O.C. Farmaceutici S.r.l.
Osteoarthritis, Knee
Long-term Safety and Performance of KiOmedine CM-Chitosan Supplementation in Advanced Symptomatic Knee Osteoarthritis
A single-blind randomized controlled design intended for the assessment of safety and performance of a single intra-articular injection of the IMD.
- Trial name
- PIONEER (NCT05214807)
- Testing
- KiOmedine® CM-Chitosan, Synvisc-One®
- Where
- Belgium
- Volunteers
- 104 people
- Sponsor
- Kiomed Pharma
de Novo Lesions in Native Coronary Arteries
First in Man Trial - BIOSOLVE-I
First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
- Trial name
- BIOSOLVE-I (NCT01168830)
- Testing
- AMS-3.0
- Where
- 6 sites in Belgium, Germany and 2 more
- Volunteers
- 46 people
- Sponsor
- Biotronik AG
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
Heart Decompensation, Heart Failure, Congestive
Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients
The study is intended to verify the safety and assess the performance of up to 3-days treatment protocol with the RenaSense System in ADHF patients.
- Conditions
- Heart Decompensation, Heart Failure, Congestive, Renal Insufficiency
- Trial name
- NCT02324400
- Testing
- RenaSense Stimulation
- Where
- 3 sites in Israel
- Volunteers
- 36 people
- Sponsor
- Nephera Ltd.
Revision Total Hip Arthroplasty, Periprosthetic Fracture of Hip
Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem.
- Trial name
- PREMO (NCT06626490)
- Testing
- Prevision Revision hip endoprosthesis stem implantation
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 120 people
- Sponsor
- Aesculap AG
Dural Defect, Cerebrospinal Fluid Leak
Immiseal™ Dural Sealant Post-Market Registry Study
This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct…
- Conditions
- Dural Defect, Cerebrospinal Fluid Leak, Neurosurgical Procedures
- Trial name
- NCT07651826
- Where
- Latvia
- Volunteers
- 85 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
The goal of this clinical trial is to assess if the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTO G2 TVSTR) is safe and efficient in treating severe tricuspid regurgitation in adult patients.
- Trial name
- FIM-TRICSTER (NCT07536724)
- Testing
- TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR)
- Where
- 2 sites in Uzbekistan
- Volunteers
- 10 people
- Sponsor
- Medira GmbH
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Hungary Satellite Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES)
- Trial name
- NCT01892917
- Where
- 13 sites in Hungary
- Volunteers
- 2,000 people
- Sponsor
- Biotronik Hungária Kft.
Fetal Growth Restriction
Evaluation of the Safety and Performance of Centaflow
The aim of this study is to evaluate the safety and performance of an acoustic approach based on skin-contact microphones as a routine assessment of placental vascular function as predictor of fetal growth restriction.
- Trial name
- NCT04438668
- Testing
- Centaflow and Standard Care, Standard Care
- Where
- 2 sites in Denmark
- Volunteers
- 1,704 people, healthy volunteers welcome
- Sponsor
- Centaflow
Sinusitis
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.
- Trial name
- NCT01623050
- Testing
- SinuSys Dilation System
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 36 people
- Sponsor
- SinuSys Corporation
Bacterial Vaginosis | Vaginal | Microbiology
Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis
This is a randomised, double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis.
- Trial name
- NCT04489290
- Testing
- D005 Vaginal Mousse
- Where
- 9 sites in Sweden, United Kingdom
- Volunteers
- 83 people
- Sponsor
- PepTonic Medical AB
Prostate Cancer
Safety and Preliminary Diagnostic Performance of [⁶⁴Cu]Cu-RAX301 in Prostate Cancer
This is a prospective, open-label, multicenter, Phase I/II exploratory diagnostic imaging study to evaluate the safety, tolerability, radiation dosimetry, pharmacokinetics, biodistribution, imaging characteristics, and…
- Trial name
- COPRA424 (NCT07765940)
- Testing
- [⁶⁴Cu]Cu-RAX301 Injection
- Volunteers
- 52 people
- Sponsor
- RadAlliance Therapeutics, Inc
Bone Regeneration, Dental Implants
Creos Xenoprotect PMCF
The goal of this retrospective PMCF study is to assess safety and performance of creos xenoprotect in all indications functioning as dental barrier membrane.
- Conditions
- Bone Regeneration, Dental Implants, Bone Grafting
- Trial name
- NCT07153185
- Testing
- Dental Barrier Membrane
- Volunteers
- 200 people
- Sponsor
- Nobel Biocare
Aortic Stenosis
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04414878
- Testing
- VitaFlow™ II Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 145 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Long Term Safety of the AMS 1.0
PROGRESS-AMS 1.0 Clinical Long Term Follow-Up
The primary objective of this study is to collect long term clinical follow-up data on all patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0
- Trial name
- NCT01610102
- Where
- 6 sites in Australia, Belgium and 3 more
- Volunteers
- 55 people
- Sponsor
- Biotronik AG
Chronic Pain
A Single Arm, Open-label First In Human Study for Assessing the Safety and Performance of the EpiFinder in Subjects With Clinical Indication for Lumbar Epidural Steroids Injection (ESI)
The EpiFinder device, which is the investigational device in this study, is intended for use in epidural procedures, between a luer syringe and an epidural needle, to give the treating physician a clear indication that the needle…
- Trial name
- NCT04047927
- Testing
- EpiFinder
- Where
- 2 sites in Israel
- Volunteers
- 15 people
- Sponsor
- Omeq Medical
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