Clinical trials: Safety and Performance
Intervertebral Disc Degeneration
Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease
The goal of this observational study is to confirm the safety and efficacy of the Hexanium ACIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal…
- Trial name
- NCT06155409
- Testing
- Anterior cervical interbody fusion
- Where
- 6 sites in France
- Volunteers
- 148 people
- Sponsor
- SPINEVISION SAS
Pre-diabetes, Undiagnosed Diseases
A Pivotal Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package
The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk.
- Trial name
- ANODE03 (NCT06261944)
- Testing
- Near-infrared (NIR)
- Where
- Spain
- Volunteers
- 486 people, healthy volunteers welcome
- Sponsor
- Glyconics Ltd
Diabetic Foot Ulcers
TITLE: An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended
An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.
- Trial name
- MxT Ag 05 (NCT01964521)
- Testing
- Mepilex Transfer Ag
- Where
- 2 sites in United Kingdom
- Volunteers
- 24 people
- Sponsor
- Molnlycke Health Care AB
Dermatitis
Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam
The scope of this open label clinical trial is to evaluate and confirm the performance of DermoRelizema ecofoam in the improvement of the dermatitis severity, by alleviating the symptomatology.
- Trial name
- NCT04826471
- Testing
- DermoRelizema ecofoam
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Relife S.r.l.
Arrythmia, Implatable Cardioverter Defibrillation, Lead
Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
The primary objective of this study is to assess the safety and electrical performance of Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped\&U-shaped: NAVIGO 4LV 2D, NAVIGO 4LV ARC) and Straight (NAVIGO 4LV PILOT)…
- Trial name
- NAVIGATOR (NCT03279484)
- Testing
- NAVIGO 4LV lead implant
- Where
- 38 sites in France, Germany and 4 more
- Volunteers
- 317 people
- Sponsor
- MicroPort CRM
Injection Site, Injection Site Reaction
Sorrel 25R Injector - Sorrel Clinical Study Protocol
A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.
- Conditions
- Injection Site, Injection Site Reaction, Injection Site Irritation
- Trial name
- NCT05221333
- Testing
- Sorrel Wearable Injector
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eitan Medical
Biliary Strictures Caused by Malignant Neoplasms
The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.
The objective of this study is to demonstrate clinical safety and performance of the HANAROSTENT® Multi-Hole™ Biliary Stent for the palliative treatment of malignant biliary obstruction.
- Trial name
- NCT07715240
- Testing
- Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction
- Volunteers
- 66 people
- Sponsor
- Olympus Corporation of the Americas
Atrial Fibrillation, Paroxysmal, Atrial Fibrillation, Persistent
MultiPulse Therapy (MPT) for AF
Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation, Paroxysmal, Atrial Fibrillation, Persistent, Atrial Fibrillation
- Trial name
- NCT04206917
- Testing
- Multi Pulse Therapy
- Where
- 6 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Cardialen, 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
Ischemic Stroke
Evaluation of the Safety and Performance of Magneto Microcatheter
A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Microcatheter in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.
- Trial name
- NCT04466033
- Testing
- Magneto Microcatheter
- Where
- 3 sites in Hungary, Israel
- Volunteers
- 4 people
- Sponsor
- Magneto Thrombectomy Solutions
Duchenne Muscular Dystrophy
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)
The study will evaluate the safety and efficacy of delandistrogene moxeparvovec gene transfer therapy in non-ambulatory and ambulatory males with DMD. This is a randomized, double-blind, placebo-controlled 2-part study.
- Trial name
- ENVISION (NCT05881408)
- Testing
- delandistrogene moxeparvovec
- Where
- 46 sites in United States, Australia and 12 more
- Volunteers
- 148 people
- Sponsor
- Sarepta Therapeutics, Inc.
Rhegmatogenous Retinal Detachment - Macula Off
Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
This study is a first-in-human clinical trial testing a new treatment for rhegmatogenous retinal detachments. The new treatment called retinal thermofusion uses a special laser device called iSeelr™ during surgery.
- Trial name
- NCT06468397
- Testing
- iSeelr™
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- Photofuse Pty Ltd
Abdominal Aortic Aneurysm, Endoleak
ANEUFIX for Endoleak Type II Repair
The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR…
- Trial name
- NCT03918460
- Testing
- ANEUFIX
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 40 people
- Sponsor
- TripleMed B.V.
Colon Cancer, Rectal Cancer
Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients
A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.
- Trial name
- NCT00867724
- Testing
- Aer-O-Scope Colonoscopy
- Where
- Israel
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- GI View Ltd.
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Spine Fracture, Degenerative Disc Disease
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications
- Conditions
- Spine Fracture, Degenerative Disc Disease, Spinal Instability, Spinal Tumor
- Trial name
- CERISE (NCT05296889)
- Testing
- posterior stabilization for the cervical spine
- Where
- 4 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Total Knee Arthroplasty
Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
The life expectancy worldwide is increasing and leading to an increase of knee arthroplasty. Also, as millions of people around the world are currently living with a Total Knee Arthroplasty (TKA), the need for revision surgery…
- Trial name
- FHK-CK (NCT06124482)
- Testing
- Total Knee arthroplasty
- Where
- 7 sites in France
- Volunteers
- 92 people
- Sponsor
- FH ORTHO
Reconstruction of the Breast Nipple and Areola Complex
Multicenter Study Evaluating the FixNip™ NRI Safety and Performance
A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.
- Trial name
- NCT04051892
- Testing
- FixNip™ NRI
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- FixNip Ltd
Peripheral Arterial Disease, Critical Lower Limb Ischemia
Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
- Trial name
- SWING (NCT04107298)
- Testing
- SUNDANCE™ Drug Coated Balloon
- Where
- 8 sites in Australia, Austria and 3 more
- Volunteers
- 35 people
- Sponsor
- SurModics, Inc.
Intracranial Aneurysms
PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France
To evaluate safety and performance of the phenox GmbH Flow Diverter p64, p64 MW, and p48MW in France, this registry will include subjects with intracranial aneurysms (anterior and posterior) who are treated with a phenox GmbH…
- Trial name
- CEFloW (NCT07748572)
- Testing
- Aneurysm treatment with a Flow Modulation Device
- Where
- 11 sites in France
- Volunteers
- 200 people
- Sponsor
- Phenox GmbH
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