Clinical trials: Safety and Performance
Roux-en-Y Gastric Bypass, Obesity
Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery
The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical used in laparoscopic RYGB surgery to create anastomoses.
- Trial name
- NCT03968757
- Testing
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- Duomed
Lip Augmentation
To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.
A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.
- Trial name
- NCT04299295
- Testing
- YVOIRE Y-Solution 360, Juvéderm VOLBELLA
- Where
- Germany
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- LG Chem
Lens Implantation, Intraocular
Evaluation of Safety and Performance Outcomes of Eyedeal IOL Implantation After Cataract Removal
A cataract is the clouding of the natural lens in the eye and is very common as when getting older. A cloudy lens makes it difficult to see.
- Trial name
- NCT05776095
- Testing
- Cataract surgery, Eyedeal® Model PX65AS1 IOL
- Where
- 2 sites in Germany, Lithuania
- Volunteers
- 97 people
- Sponsor
- Xi'an Eyedeal Medical Technology Co., Ltd
Peripheral Artery Disease, Peripheral Arterial Occlusive Disease
The EasyFlype/EasyHiFlype Post Market Clinical Follow-up Study.
The Easy Flype Carbostent™ is a CE-marked nitinol self-expanding stent for superficial femoral artery (SFA) and Easy HiFlype Carbostent™is a CE-marked nitinol self-expanding stent for iliac vessels.
- Trial name
- NCT05616169
- Testing
- Easy Flype/EasyHiFlype
- Where
- 2 sites in Italy
- Volunteers
- 52 people
- Sponsor
- CID S.p.A.
Sport Surgery
Sport Surgery Products Outcomes - A Post-market Follow-up
Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products.
- Trial name
- NCT06532929
- Testing
- Orthopaedic surgeries (ankle), Orthopaedic surgeries (shoulder), Orthopaedic surgeries (knee)
- Where
- 10 sites in France
- Volunteers
- 390 people
- Sponsor
- Teknimed
Fluid Responsiveness Predictability, Hemodynamic Monitoring
Comparison of Acoustic Variability Index (AVI) and Pulse Pressure Variation (PPV) for Predicting Fluid Responsiveness in Mechanically Ventilated Patients
The goal of this clinical trial is to learn if a new medical device called ResQ works to predict fluid needs in adults undergoing surgery under general anesthesia.
- Conditions
- Fluid Responsiveness Predictability, Hemodynamic Monitoring, Anesthesia, General
- Trial name
- NCT07516470
- Testing
- Biological Signal Processing Device for Acoustic Variability Index, Patient monitor for pulse pressure variation, Hemodynamic monitor for cardiac Output and stroke volume variation
- Where
- South Korea
- Volunteers
- 122 people
- Sponsor
- Signal House Co., Ltd.
Pacemaker, Bradycardia
Adapta Pacing System Clinical Study
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow).
- Trial name
- NCT00307073
- Testing
- Implantable Pulse Generator
- Where
- 7 sites in Austria, Czechia and 4 more
- Volunteers
- 120 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Skin Fold, Skin Laxity
A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology)
The current post-market clinical investigation has been designed to evaluate the efficacy and safety of CELLBOOSTER® Lift, a HA-based product marketed by SUISSELLE SA.
- Conditions
- Skin Fold, Skin Laxity, Skin Texture Disorder, Skin Depression
- Trial name
- NCT06000839
- Testing
- (D0) Intradermal injection - micropapula technique, (D14) Intradermal injection - micropapula technique, (D28) Intradermal injection - micropapula technique
- Where
- France
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Suisselle
Psoriasis
Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Psoriasis
This PMCF study is to obtain patient feedback using online questionnaires. There will be no involvement from healthcare professionals (HCPs) or investigator sites.
- Trial name
- NCT07817394
- Testing
- Doublebase Once
- Volunteers
- 100 people
- Sponsor
- Dermal Laboratories Ltd
Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children
Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).
- Trial name
- PUL (NCT02106351)
- Testing
- Botulinum toxin type A
- Where
- 31 sites in United States, Belgium and 6 more
- Volunteers
- 212 people
- Sponsor
- Ipsen
Anterior Cruciate Ligament Injury, Rotator Cuff Tear
MDR EZ Pass and Precision Flexible Reamer
The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
- Trial name
- NCT03914703
- Testing
- EZ Pass Suture Passer
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Zimmer Biomet
Osteoarthritis of Knee
RCT on the Performance and Safety of LightForce® Therapy Lasers on Knee Osteoarthritis Pain Reduction (SPARK)
DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in subjects with unilateral or bilateral knee osteoarthritis.
- Trial name
- SPARK (NCT06654739)
- Testing
- Laser therapy + physiotherapy/exercise protocol
- Where
- 7 sites in France, Italy and 1 more
- Volunteers
- 64 people
- Sponsor
- DJO UK Ltd
Heart Failure
Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)
The purpose of the ENDO-HF study is to determine the safety \& performance of the Harmony System for the treatment of heart failure
- Trial name
- NCT02633644
- Testing
- Harmony System
- Where
- 5 sites in Belgium, Croatia and 2 more
- Volunteers
- 30 people
- Sponsor
- Enopace Biomedical
Degenerative Disc Disease, Spondylolisthesis
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- Trial name
- NCT04416321
- Testing
- Surgery with the Keos Lumbar Interbody Fusion Device
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Invibio Ltd
Hip Arthropathy
Assessment of Safety and Performances of HYPE SCS Stem Associated to NOVAE Sunfit TH Acetabular Cup in Hip Arthroplasty
Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures.
- Trial name
- 2020-04 (NCT05524363)
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
Corneal Disease, Corneal Opacity
Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness
A Single Arm, Pivotal, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness
- Conditions
- Corneal Disease, Corneal Opacity, Corneal Injuries
- Trial name
- NCT05694247
- Testing
- CorNeat KPro
- Where
- 6 sites in Canada, France and 2 more
- Volunteers
- 15 people
- Sponsor
- CorNeat Vision Ltd.
Plaque Psoriasis
Investigation With BiopH+Psoriasis Medical Bath in Subject With Mild to Moderate Plaque Psoriasis.
The purpose of this investigation is to assess performance and safety of BIOpH+ Psoriasis Medical Bath in comparison to a comparative device.
- Trial name
- NCT05046899
- Testing
- BIOpH+ Psoriasis Medical Bath, Cetaphil Moisturizing Lotion
- Where
- Sweden
- Volunteers
- 25 people
- Sponsor
- Biocool AB
Vaginal Dryness
Performance and Safety of MUCOGYNE® Ovule as a Moisturizer
The aim of this post-Market Clinical Follow-up (PMCF) study is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural…
- Trial name
- MOVHYDA (NCT06282614)
- Testing
- Mucogyne Ovule
- Where
- 3 sites in France
- Volunteers
- 33 people
- Sponsor
- Biocodex
Prostate Cancer
Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer
The goal of this clinical trial is to test if the experimental agent accurately determines the aggressiveness of prostate cancer (biopsy-verified ISUP grade).
- Trial name
- uTRACE-101 (NCT06474806)
- Testing
- 64Cu-DOTA-AE105
- Where
- 9 sites in Denmark, Germany and 1 more
- Volunteers
- 168 people
- Sponsor
- Curasight
Atrial Fibrillation
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that…
- Trial name
- NCT06099106
- Testing
- SEPIOLA System
- Where
- 5 sites in Georgia, Lithuania and 2 more
- Volunteers
- 15 people
- Sponsor
- Endomatic Ltd.
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