Clinical trials: Clinical Performance
COVID-19
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
The purpose of this study is to evaluate the performance of the Bio-Self COVID-19 Antigen Home Test. The study will evaluate the accuracy (sensitivity and specificity) in a simulated home use environment when compared to a…
- Trial name
- NCT05334758
- Testing
- Bio-Self COVID-19 Antigen Home Test, Standard of Care COVID-19 Test, RT-PCR Test
- Where
- 3 sites in United States
- Volunteers
- 282 people, healthy volunteers welcome
- Sponsor
- BioTeke USA, LLC
Osteogenesis Imperfecta
Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients
This study has been planned as part of the Orthofix Srl post-market active surveillance plan for the collection of data on both the clinical performance and the safety profile of the JTIN.
- Trial name
- JTIN (NCT05612139)
- Testing
- JTIN implantation surgery
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Orthofix s.r.l.
Cardiothoracic Surgery
Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.
- Trial name
- NCT03725098
- Testing
- HEMOBLAST Bellows, FLOSEAL
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Biom'Up France SAS
Deformity, Defect, Congenital
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of…
- Conditions
- Deformity, Defect, Congenital, Trauma
- Trial name
- JPS (NCT05245617)
- Testing
- JuniOrtho™ Plating System™
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Orthofix s.r.l.
Venous Leg Ulcer
Diagnostics in the Leg Ulcer Pathway
This project aims to investigate 'The minimum diagnostic requirements for patients presenting to primary care with suspected venous ulcers.' In order to do this, the investigators intend to run a series of questionnaires with…
- Trial name
- NCT06181708
- Testing
- N/A - Questionnaire based study
- Where
- United Kingdom
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Human Leukocyte Antigens (HLA)
Clinical Protocol SeCore, uTYPE and 3500 Dx System
The purpose of this study is to compare the Invitrogen SeCore(R) sequencing system and uTYPE(R) interpretation software to the predicate device Invitrogen SSP UniTray(R) with UniMatch(R) interpretation software and show 95%…
- Trial name
- NCT01285427
- Volunteers
- 300 people
- Sponsor
- Life Technologies Corporation
Malocclusion
Clinical Performance of a New Esthetic, Self-ligating Orthodontic Bracket
A cohort of 15 patients starting orthodontic treatment with fixed appliances will receive EXD-952 Ceramic Self-ligating brackets on all mandibular incisors and a different type of brackets on the remaining mandibular teeth.
- Trial name
- NCT02959671
- Testing
- Lower Anterior EXD-952 Self-ligating Brackets
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of Minnesota
Dental Caries
High-strength Glass-ionomer Dental Restorations
The purpose of this study is to extend our knowledge concerning the clinical performance of two dental filling materials in molars. The study will compare two high-strength glass-ionomer filling materials.
- Trial name
- ROCK (NCT01523613)
- Testing
- Chemfil ROCK Glassionomer restoration, Fuji IX GP Extra Glassionomer restoration
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- Mathilde Peters, DMD, PhD
Incontinence, Urge
T-DOC® 5 Fr Pediatric Clinical Investigation
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
- Trial name
- NCT03429270
- Testing
- TDOC 5Fr
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Cognition
A Clinical Trial to Study the Impact of a Nutritional Beverage on Tests of Memory in Healthy Preschool Age Children
The effect of supplementation using both protein and multiple micronutrients in preschool age children on cognitive performance and growth is unknown.
- Trial name
- NCT02177942
- Testing
- Test beverage powder (High Proteins and added micronutrients), Control beverage powder (Low protein and no added micronutrients)
- Where
- India
- Volunteers
- 528 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Fever, Healthy
Clinical Performance of Masimo INVSENSOR00048
The objective of this clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.
- Trial name
- NCT06289556
- Testing
- Masimo INVSENSOR00048
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Burn Injury, Skin Graft
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn…
- Trial name
- MpTAg03 (NCT02210208)
- Testing
- Mepitel® Ag, Mepilex® Transfer Ag
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Molnlycke Health Care AB
Cancer
Assessing the Performance of Artificial Intelligence (AI)-Augmented Electronic Health Record (EHR) Data Abstraction for Clinical Trial Patient Screening
Identifying eligible patients is a key process in the clinical trial enterprise. Currently, this process relies on time-intensive manual chart review, creating a rate-limiting step for trial participation.
- Trial name
- NCT06561217
- Testing
- Chart review
- Where
- 2 sites in United States
- Volunteers
- 355 people
- Sponsor
- University of Pennsylvania
Hemorrhage, Surgical
Clinical Safety and Performance of GATT-Patch in Open Liver Surgery
The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.
- Trial name
- NCT04819945
- Testing
- GATT-Patch
- Where
- 3 sites in Netherlands
- Volunteers
- 56 people
- Sponsor
- GATT Technologies BV
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
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Blood Pressure
Clinical Evaluation of the Performance of Bionet Sphygmomanometer Modules Based on Protocol Presented by the International Organization for Standardization
According to INTERNATIONAL STANDARD (hereafter ISO) blood pressure (BP) monitor clinical evaluation protocol (ISO 81060-2:2018, Non-invasive sphygmomanometers- Part2: Clinical investigation of intermittent automated measurement…
- Trial name
- NCT06609486
- Testing
- Blood pressure measurement group
- Where
- South Korea
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Hoon-Ki Park
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.
Infertility
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial…
- Trial name
- ENDOMEDE (NCT03387059)
- Testing
- Forielle
- Where
- 7 sites in Italy
- Volunteers
- 9 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Septoplasty
Safety and Performance of ENTACT Septal Staple System for Septoplasty
This is a prospective, multi-center, single arm PMCF study to evaluate the safety and performance of the ENTACT (Next Generation) resorbable staple system for septoplasty in 40 subjects.
- Trial name
- NCT04392583
- Testing
- ENTACT Septal Staple system
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.