Clinical trials: Performance and Safety
Parkinson Disease, Cognitive Impairment
Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
Prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus to improve cognitive performance in patients with advanced Parkinson's disease.
- Trial name
- NCT03204526
- Testing
- deep brain stimulation
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of California, Davis
Colorectal Liver Metastases (CRCLM)
To Evaluate the Performance of HepaSphere Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy on Unresectable Colorectal Liver Metastases
Both drug-eluting bead transarterial chemoembolization (DEB-TACE) and hepatic arterial infusion chemotherapy (HAIC) are recommended for unresectable colorectal liver metastases (CRLM) treatment.
- Trial name
- NCT05889325
- Testing
- DEB-TACE plus HAIC
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Peking University Cancer Hospital & Institute
Hemostasis
Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery
- Trial name
- NCT04471350
- Testing
- HEMOBLAST™ Bellows
- Where
- France
- Sponsor
- Biom'Up France SAS
Brain Tumor Adult, Epilepsy
WISE Cortical Strip for Intraoperative Neurophysiological Monitoring
The WIN Study is a prospective, interventional, multi-center, open-label premarket study designed to confirm the safety, performance and intended use of the WISE Cortical Strip (WCS) for CE certification purposes.
- Trial name
- WIN (NCT03731455)
- Testing
- WISE Cortical Strip
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 32 people
- Sponsor
- Wise S.r.l.
Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices.
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures
- Trial name
- NCT05227924
- Testing
- Total hip arthroplasty (primary or revision)
- Where
- 9 sites in France
- Volunteers
- 747 people
- Sponsor
- Dedienne Sante S.A.S.
Coronary Artery Stenosis
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family
The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
- Trial name
- NCT05536180
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Arthesys
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
Mild to Moderate Acute Respiratory Distress Syndrome
Post-Market Study of Low-flow ECCO2R Using PrismaLung+
PrismaLung+ is intended to provide extracorporeal carbon dioxide removal (ECCO2R) as a standalone therapy or in combination with continuous renal replacement therapy (CRRT).
- Trial name
- NCT04617093
- Testing
- PrismaLung+
- Where
- 10 sites in France
- Volunteers
- 63 people
- Sponsor
- Vantive Health LLC
Mild Defects of the Lips
Post-Market Clinical Follow-up (PMCF) Study of Safety and Performance of 300-01 RefillHA Lips
A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips
- Trial name
- NCT07831213
- Where
- Israel
- Volunteers
- 87 people
- Sponsor
- Glyance
Peripheral Arterial Disease
Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent in the Superficial Femoral Artery
This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions.
- Trial name
- BOSS (NCT01499342)
- Where
- 2 sites in Belgium
- Volunteers
- 435 people
- Sponsor
- be Medical
Ostomy
Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™
The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.
- Trial name
- NCT01261988
- Testing
- VIPER, Esteem™ Cut to Fit One Piece Closed End Pouch
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- ConvaTec Inc.
Bowel Dysfunction
En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device.
This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the…
- Trial name
- NCT06377280
- Testing
- Navina Mini
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Wellspect HealthCare
Clostridium Difficile Infection
Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)
The purpose of this study is to determine the safe use and evaluate the efficacy/performance of DAV132 in hospitalized patients at high risk for Clostridium difficile infection (CDI) and who receive fluoroquinolones (FQs) for the…
- Trial name
- SHIELD (NCT03710694)
- Testing
- DAV132
- Where
- 29 sites in Bulgaria, Germany and 2 more
- Volunteers
- 260 people
- Sponsor
- Da Volterra
Nasolabial Fold, Safety
A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds. There is an 18 months follow up period.
- Trial name
- NCT03300466
- Testing
- GP0045, Comparator
- Where
- Sweden
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Healthy Subjects, Rheumatoid Arthritis
Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis
This study evaluates safety, tolerability, biodistribution and performance of the [68Ga]Ga-DOTA-Siglec-9 following a single intravenous administration in patients with active rheumatoid arthritis, vasculitis or pulmonary…
- Conditions
- Healthy Subjects, Rheumatoid Arthritis, Vasculitis, Pulmonary Sarcoidosis
- Trial name
- SIGLEC (NCT03755245)
- Testing
- [68Ga]Ga-DOTA-Siglec-9
- Where
- Finland
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Turku University Hospital
Safety and Effectiveness of the Siello S Lead
Safety and Performance Study of the Siello S Pacing Lead
The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.
- Trial name
- SIELLO (NCT01791127)
- Testing
- market-released BIOTRONIK pacemaker system including one or two Siello S leads.
- Where
- 53 sites in United States
- Volunteers
- 1,758 people
- Sponsor
- Biotronik, Inc.
Low Back Pain
Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
The JAPET.W+ medical device is a new dynamic distraction support system. It could be considered as a new solution in the therapeutic arsenal for managing common low back pain.
- Trial name
- EXODOMICILE (NCT07195422)
- Testing
- Japet.W+, Control (Standard treatment)
- Where
- 2 sites in France
- Volunteers
- 102 people
- Sponsor
- Japet Medical Devices
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
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
Spinal Cord Injuries
Beta-alanine Supplementation and Its Effects on Performance, Muscle Carnosine Content and Safety in Athletes With Spinal-cord Injury
Paralympians competing in wheelchair sports may experience a very high glycolytic demand (and therefore acidotic environment) in their upper-body muscles, particularly in high-intensity disciplines.
- Trial name
- NCT02604927
- Testing
- Beta-alanine, Dextrose
- Where
- Brazil
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo