Clinical trials: Clinical Performance
Performance and Tolerance of Colonoscopy
Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study
Colonoscopy is the gold-standard for colorectal cancer screening in the US. However, complete colonoscopy can be a challenging technical procedure, even for expert gastroenterologists due to variations in patient anatomy…
- Trial name
- C3PO (NCT02025504)
- Testing
- ColoWrap
- Where
- 3 sites in United States
- Volunteers
- 350 people
- Sponsor
- ColoWrap, LLC
Wrist Fracture, Proximal Humerus Fracture
PMCF Study on the Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System
The study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the XtraFix® Small External…
- Trial name
- NCT05943574
- Where
- Italy
- Volunteers
- 91 people
- Sponsor
- Zimmer Biomet
Wound and Injuries, Surgical Wound Dehiscence
The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds
The study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting.
- Trial name
- NPWT (NCT02565043)
- Testing
- RENASYS TOUCH Negative Pressure Wound Therapy System
- Where
- 2 sites in South Africa
- Volunteers
- 80 people
- Sponsor
- Smith & Nephew, Inc.
Bloodstream Infection, Sepsis
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care…
- Conditions
- Bloodstream Infection, Sepsis, Septic Shock
- Trial name
- IID-BSIqPCR (NCT06531031)
- Testing
- InfectID-BSI (Bloodstream Infection) qPCR Assay
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 1,500 people
- Sponsor
- Microbio Co Ltd
Enterostomy, Stoma Ileostomy
Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
The study is designed as a non-interventional, prospective, international, multi-center, post market follow-up investigation. The product under investigation will be used in routine clinical practice and according to Instructions…
- Conditions
- Enterostomy, Stoma Ileostomy, Stoma Colostomy
- Trial name
- NCT05373888
- Testing
- Flexima®/Softima® stoma bags
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- BBraun Medical SAS
Bacterial Vaginosis
Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed bacterial vaginosis (BV) according to fulfillment of at least 3…
- Trial name
- NCT03762083
- Testing
- pHyph generation I
- Where
- 2 sites in Sweden
- Volunteers
- 24 people
- Sponsor
- Gedea Biotech AB
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Anastomosis, Surgical
Evaluation of MUSA-3 in Microsurgical Anastomoses
This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system.
- Trial name
- NCT07427823
- Testing
- Robot-assisted microsurgical anastomoses
- Volunteers
- 30 people
- Sponsor
- Microsure
Caries Pit and Fissure Limited to Enamel
Clinical Performance of Two Fissure Sealants
Comparison of the retention of a new fissure sealant (Helioseal F Plus) and a fissure sealant that has been on the market for years in children
- Trial name
- NCT03470129
- Testing
- fissure sealing
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Ivoclar Vivadent AG
Dental Prosthesis, Implant-Supported
A Retrospective Data Collection on NobelProcera® Zirconia Implant Bridges from 4 to 14 Units.
This is a retrospective multicenter data collection in which clinical and radiographic data on implant zirconia bridges are collected from partially or fully edentulous subjects consecutively treated with at least one 4- to…
- Trial name
- NCT06600451
- Testing
- observational study, no intervention is required
- Where
- Switzerland
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Nobel Biocare
End Stage Renal Disease
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts
The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.
- Trial name
- NCT00131872
- Testing
- Expedial Vascular Access Graft
- Where
- 8 sites in United States
- Volunteers
- 172 people
- Sponsor
- LeMaitre Vascular
Autoimmune Diseases
Clinical Performance of the New Plasma Filter PX2 in TPE Treatments
The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased…
- Trial name
- plasmaFlux (NCT06382675)
- Testing
- Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2
- Where
- 7 sites in Germany
- Volunteers
- 46 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
Herpes Labialis
Study of a Cold Sore Patch for the Treatment of Herpes Labialis
If a person qualifies to participate in this study, they will have an equal chance of being assigned to either of two groups. One group will receive a patch that they will need to carry with them, because as soon as a cold sore…
- Trial name
- NCT01484067
- Testing
- Patch ( Compeed© Total CareTM Cold Sore Patch)
- Where
- United Kingdom
- Volunteers
- 472 people
- Sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Chronic Low-back Pain, Degenerative Disc Disease
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome
- Trial name
- ARREST (NCT05944081)
- Testing
- ArcadiusXP L® Interbody Fusion System
- Where
- 3 sites in Germany
- Sponsor
- Aesculap AG
Migraine
A Proof of Concept Alleviating the Symptoms of Photosensitive Migraine.
This proof of concept clinical study will investigate the efficacy of active lens with frame in alleviating the symptoms of migraine which are caused by photosensitivity.
- Trial name
- NCT04904328
- Testing
- Lumishade® Active Lens
- Volunteers
- 77 people
- Sponsor
- Mitsui Chemicals, Inc.
Skin Resurfacing, Wrinkle Reduction
Clinical Study to Evaluate the Performance of Fractional Radiofrequency for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction
The purpose of this study is to determine whether the Matrix RF applicator is effective in the treatment of facial skin texture and wrinkle reduction.
- Trial name
- NCT00887913
- Testing
- Fractional RF treatment with Matrix RF applicator
- Where
- 3 sites in United States, Canada
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Syneron Medical
Malaria
Clinical Performance Evaluation of Fyodor Urine Malaria Test (UMT)
The purpose of this study is to evaluate the clinical performance of the one-step Fyodor Urine Malaria Test (UMT), to determine its accuracy (sensitivity and specificity) for the diagnosis of Plasmodium falciparum malaria in…
- Trial name
- NCT01921413
- Testing
- Urine Malaria Test
- Where
- Nigeria
- Volunteers
- 1,893 people, healthy volunteers welcome
- Sponsor
- Fyodor Biotechnologies Inc
Down Syndrome, Fetal Aneuploidy
Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies
Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.
- Trial name
- NCT01555346
- Where
- 29 sites in United States, Canada
- Volunteers
- 3,062 people
- Sponsor
- Sequenom, Inc.
Healthy
Clinical Performance of Masimo Rad-GT
The study is designed to validate the clinical performance of Masimo Rad-GT in the accuracy of temperature measurements.
- Trial name
- NCT05779397
- Testing
- Masimo RAD-GT
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
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