Clinical trials: Performance and Safety
Substance Use Disorder (SUD)
A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication
This is a post-market clinical follow-up study on an approved CE-marked eHealth system where a mobile phone application is used to measure the pupils and eye measurements to monitor the use of different drug substances.
- Trial name
- NCT06629740
- Testing
- Measurements with a eHealth system
- Where
- Netherlands
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Kontigo Care AB
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
Cognitive Measures, Driving Simulator Performance
Phenytoin and Driving Safety: A Randomized, Controlled Cross-Over Study
Automobile driving is a crucial aspect of everyday life, yet vehicular crashes represent a serious public health problem. Patients with epilepsy are at elevated risk for automobile crashes, causing great personal suffering and…
- Trial name
- NCT00581893
- Testing
- Phenytoin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Iowa
Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV
Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients.
- Trial name
- NCT03085238
- Testing
- M-Trap
- Where
- 8 sites in Spain
- Volunteers
- 23 people
- Sponsor
- MTrap, Inc.
Eczema, Psoriasis
A Clinical Investigation With Epaderm® Cream
This investigation is designed as a prospective, non-randomised, single arm clinical investigation. Data is collected from approximately 120 evaluable subjects, divided into three groups of approximately 40 subjects; infants…
- Conditions
- Eczema, Psoriasis, Dry Skin; Eczema
- Trial name
- PD-539878 (NCT03738163)
- Testing
- Epaderm Cream
- Where
- 2 sites in United Kingdom
- Volunteers
- 121 people
- Sponsor
- Molnlycke Health Care AB
Ileostomy - Stoma
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
- Trial name
- NCT01957553
- Testing
- Coloplast test product, SenSura
- Where
- 17 sites in Belgium, Denmark and 3 more
- Volunteers
- 130 people
- Sponsor
- Coloplast A/S
Femoral Arteriotomy Closure
MANTA Registry for Vascular Large-bore Closure
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for…
- Trial name
- MARVEL (NCT03330002)
- Testing
- CE-marked MANTA vascular closure device (VCD)
- Where
- 9 sites in Canada, Denmark and 3 more
- Volunteers
- 500 people
- Sponsor
- Essential Medical, Inc.
Intracranial Aneurysm
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial…
- Trial name
- SUNRISE (NCT00486226)
- Testing
- Vascular Reconstruction Device
- Where
- Belgium
- Volunteers
- 105 people
- Sponsor
- Codman & Shurtleff
Venous Leg Ulcer (VLU)
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT02167815
- Testing
- Mepilex XT, standard care
- Where
- 3 sites in Czechia
- Volunteers
- 30 people
- Sponsor
- Molnlycke Health Care AB
Bone Substitutes, Bone Defect
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects…
- Trial name
- NCT03884790
- Testing
- surgical repair of long bone defects
- Where
- 8 sites in Bosnia and Herzegovina, Israel and 4 more
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.
Pregnancy
Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
- Trial name
- NCT03504189
- Testing
- PregSense™, Cardiotocopraphy (CTG)
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 151 people
- Sponsor
- Nuvo-Group, Ltd.
Polyp of Colon, Endoscopic Mucosal Resection
EndoRotor® Endoscopic Mucosal Resection System for the Colon
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic…
- Conditions
- Polyp of Colon, Endoscopic Mucosal Resection, Recurrent Colon Adenoma
- Trial name
- NCT04203667
- Testing
- EndoRotor Resection
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 66 people
- Sponsor
- Interscope, Inc.
Carotid Artery Diseases, Stroke
Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with…
- Trial name
- WISE (NCT01783639)
- Testing
- Carotid Artery Stent
- Where
- 10 sites in Belgium, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- Gardia Medical
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
Intracranial Aneurysm
Coil Assisted Flow Diversion Safety and Performance Study
Cerus Endovascular is sponsoring a prospective, single arm, multi-center study to document the safety and performance of Neqstent in adjunctive therapy.
- Trial name
- CAFI (NCT04187573)
- Testing
- Neqstent
- Where
- 7 sites in Austria, Canada and 3 more
- Volunteers
- 38 people
- Sponsor
- Cerus Endovascular, Inc.
Cochlear Hearing Loss
Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiRes Ultra Cl HiFocus MS Electrode and HiRes Ultra 3D Cl HiFocus MS Electrode (Ultra X) under normal conditions of use as it is approved for this…
- Trial name
- NCT04610112
- Testing
- Cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Advanced Bionics AG
Infrarenal Abdominal Aortic Aneurysms, Aortoiliac Aneurysms
HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm
Clinical Investigation Design A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.
- Trial name
- NCT02087501
- Testing
- Horizon™ Abdominal Aortic Aneurysm Stent Graft System
- Where
- 7 sites in Italy, Netherlands and 2 more
- Volunteers
- 30 people
- Sponsor
- Endospan Ltd.
Labral Tear, Glenoid, Acetabular Labrum Tear
Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors…
- Conditions
- Labral Tear, Glenoid, Acetabular Labrum Tear, Bankart Lesions, Anterior Shoulder Instability
- Trial name
- NCT03985839
- Testing
- MICRORAPTOR™ REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless PEEK Suture Anchor
- Where
- 12 sites in United States
- Volunteers
- 298 people
- Sponsor
- Smith & Nephew, Inc.
Meniscus Tear
Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations
This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair…
- Trial name
- FAST-FIX FLEX (NCT04903106)
- Testing
- FAST-FIX FLEX Meniscal Repair System
- Where
- 5 sites in United States, Australia and 2 more
- Volunteers
- 63 people
- Sponsor
- Smith & Nephew, Inc.
Chronic Sinusitis
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.
- Trial name
- S8PK (NCT01894503)
- Testing
- S8 Sinus Implant (mometasone furoate, 1350 mcg)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Intersect ENT