Clinical trials: Safety and Performance
Multiple Sclerosis, Spasticity, Muscle
Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain
This study is based on a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS)…
- Conditions
- Multiple Sclerosis, Spasticity, Muscle, Pain
- Trial name
- NCT05598736
- Testing
- FlowOx 2.0
- Where
- Norway
- Volunteers
- 58 people
- Sponsor
- Otivio AS
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
Hepatic Tumor
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
- Trial name
- NCT04230642
- Testing
- The Quantum Surgical device
- Where
- 2 sites in France
- Volunteers
- 22 people
- Sponsor
- Quantum Surgical
Leakage, Skin Condition
Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy
Introduction: It is not an illness to have an ostomy, even though it is an indication of previous serious illness, such as cancer, which is the reason for approximately 80% of all ostomy operations.
- Trial name
- NCT01448629
- Testing
- Standard Care, River
- Sponsor
- Coloplast A/S
Digital Nerve Injury
TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial
The purpose of this study is to collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial…
- Trial name
- NCT04327154
- Testing
- TISSIUM™ Nerve Coaptation Device
- Where
- 2 sites in Australia
- Volunteers
- 12 people
- Sponsor
- Tissium
Abdomino-pelvic Surgery, Bleeding
A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding
This research conducted by EMBOBIO SAS is intended for patients with bleeding or at risk of bleeding in the abdominal-pelvic region requiring embolization.
- Conditions
- Abdomino-pelvic Surgery, Bleeding, Embolization
- Trial name
- EMBOBIO-1 (NCT07199348)
- Testing
- Embobio
- Where
- France
- Volunteers
- 45 people
- Sponsor
- Embobio Medical
Bowel Dysfunction
An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents
The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents.
- Trial name
- NCT06385249
- Testing
- Navina Mini
- Where
- Sweden
- Volunteers
- 27 people
- Sponsor
- Wellspect HealthCare
Primary Open Angle Glaucoma
Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma
It is an interventional study for the treatment of Primary Open-Angle Glaucoma (POAG) using the Hexiris Microinvasive Scleral Trephine (MIST) system. This medical device includes a sclerectomy punch and injector assembly.
- Trial name
- NCT07358650
- Testing
- Hexiris Microinvasive Scleral Trephine (MIST)
- Where
- 5 sites in Canada
- Volunteers
- 25 people
- Sponsor
- Hexiris Inc
Carotid Artery Stenosis
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)
Clinical Trial Summary Trial Title:** CREATE Trial: Safety and Efficacy of IVL for Carotid Calcified Lesions Sponsor:** Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Trial name
- CREATE (NCT06936176)
- Testing
- Neurovascular Intravascular Shockwave Catheter
- Where
- China
- Volunteers
- 204 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Degenerative Disc Disease, Degenerative Spondylolisthesis
TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)
In recent years there has been an increase in interest from surgeons in the use of synthetic bone graft substitutes to avoid the need of sourcing allograft or iliac crest autograft for use in spinal fusion procedures.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT05114135
- Testing
- Osteo3 ZP Putty
- Where
- Hungary
- Volunteers
- 17 people
- Sponsor
- OssDsign
Dentistry, Dental Implant
Performance and Safety Use of the Mono Block Implant "KONTACT MB"
A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue…
- Conditions
- Dentistry, Dental Implant, Dental Restoration, Implant-supported Fixed Prosthesis
- Trial name
- NCT05016258
- Testing
- KONTACT MB
- Where
- France
- Volunteers
- 159 people
- Sponsor
- Biotech Dental
Hemostasis
Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.
- Trial name
- NOBLE-Open (NCT03873168)
- Testing
- HEMOBLAST™ Bellows
- Where
- 9 sites in Austria, France and 1 more
- Volunteers
- 64 people
- Sponsor
- Biom'Up France SAS
Degenerative Instability, Spondylolisthesis
PMCF Study on the Safety and Performance of CESPACE 3D
Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Trial name
- CATALINA (NCT04477447)
- Where
- 2 sites in Germany
- Volunteers
- 101 people
- Sponsor
- Aesculap AG
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
Peripheral Arterial Disease Below The Knee
Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention in the Popliteal and/or Infrapopliteal Arteries
The rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK…
- Trial name
- POP-BTK (NCT05267548)
- Where
- 8 sites in Belgium
- Volunteers
- 143 people
- Sponsor
- iVascular S.L.U.
Diabetes Mellitus
Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device
This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.
- Trial name
- NCT03352518
- Testing
- WM3.4NR
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- RSP Systems A/S
Renal Failure, End Stage Renal Disease
Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration
The clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration
- Trial name
- eMPORA II (NCT03611218)
- Testing
- Dialyzer
- Where
- 6 sites in Germany
- Volunteers
- 71 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Ventricular Tachycardia (VT)
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the…
- Trial name
- NCT06703489
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Peripheral Arterial Disease
XPAD European Feasibility Study
A prospective, single arm, non-randomized European feasibility study to evaluate the safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective…
- Trial name
- NCT07716020
- Testing
- XPAD conduit
- Volunteers
- 15 people
- Sponsor
- Xeltis
Facial Lipoatrophy, Morphological Asymmetry of the Face
Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or Scars
In this study, eligible patients with the medical indications (facial lipoatrophy, morphological asymmetry of the face, or debilitating scars) will be treated with Princess® FILLER, and then will return for follow-up assessments…
- Conditions
- Facial Lipoatrophy, Morphological Asymmetry of the Face, Debilitating Scars
- Trial name
- FLASH 1 (NCT03050723)
- Testing
- Princess® FILLER
- Where
- 3 sites in Austria
- Volunteers
- 53 people
- Sponsor
- Croma-Pharma GmbH
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