Clinical trials: Clinical Performance
- Condition Clinical Performance
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Chronic Functional Constipation
Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months
The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-
- Trial name
- NCT02751411
- Testing
- micro-enema with Promelaxin, Macrogol 4000
- Where
- 4 sites in Italy
- Volunteers
- 158 people
- Sponsor
- Aboca Spa Societa' Agricola
Dental Caries, Insufficient Dental Filling
A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth
The overall aim of this clinical investigation is to assess the clinical performance and safety of composite restorations cured with fast curing mode (5 seconds with 2000 mW/cm²) in primary molars.
- Trial name
- NCT07212660
- Testing
- Fast curing mode, Conventional curing mode
- Where
- 2 sites in Switzerland
- Volunteers
- 70 people
- Sponsor
- Ivoclar Vivadent AG
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
Temporomandibular Joint Disorders
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
This is a long-term (10 years), retrospective-prospective, observational, single-arm, monocenter study of patients to be treated with the Materialise TMJ Total Arthroplasty System for TMJ replacement.
- Trial name
- NCT06951178
- Testing
- TMJ Total Arthroplasty System (TMJ System)
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Materialise
Respiratory Disease
QIAstat-Dx® Respiratory Panel Plus (RPP) Clinical Performance Study
This study will evaluate the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method
- Trial name
- NCT05733559
- Testing
- QIAstat-Dx® Respiratory Panel Plus (RPP)
- Where
- United Kingdom
- Volunteers
- 565 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Blood Disease
QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study
Study for performance evaluation of the QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel in comparison with other chosen comparator methods
- Trial name
- NCT05305534
- Testing
- QIAstat-Dx® BCID GN and GPF Plus AMR Panels
- Where
- United Kingdom
- Volunteers
- 2,142 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Abdominal Vascular Surgery, Peripheral Vascular Surgery
A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C
Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and…
- Conditions
- Abdominal Vascular Surgery, Peripheral Vascular Surgery, Vascular Prothesis, Aneurysm Abdominal
- Trial name
- NCT05517876
- Testing
- Vascular abdominal or peripheral surgery
- Where
- France
- Volunteers
- 212 people
- Sponsor
- Perouse Medical
Streptococcus Pyogenes Infection, Pharyngitis
Clinical Performance of the Checkable Medical At-Home Strep A Test
The Checkable Medical At-Home Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Group A Strep (GAS) antigens from throat swabs.
- Conditions
- Streptococcus Pyogenes Infection, Pharyngitis, Respiratory Tract Infections
- Trial name
- NCT05107362
- Testing
- untrained lay user performs investigational diagnostic test
- Where
- 22 sites in United States
- Volunteers
- 1,347 people
- Sponsor
- Checkable Medical 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.
Diaper Rash
Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash
Result of immaturity of the skin and factors promoting maceration and mechanical interactions, Irritant diaper dermatitis (IDD) can manifest as early as the third week of life.
- Trial name
- NCT03640897
- Testing
- Liniderm, Wipes, Water
- Where
- Poland
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Laboratoires Gilbert
Dental Restoration, Permanent, Dental Restorations
Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
The aim of this present study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in all its indications.
- Conditions
- Dental Restoration, Permanent, Dental Restorations, Endodontic Treatment
- Trial name
- BIOD XP (NCT06955429)
- Testing
- Dental restorative or endodontic treatment requiring Biodentine XP use
- Where
- 8 sites in Belgium, France
- Volunteers
- 275 people
- Sponsor
- Septodont
Transfusion Reaction
Clinical Performance Study of Safety Test ABO Device
The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.
- Trial name
- NCT06543771
- Testing
- Safety Test ABO and ABTest Card®
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Diagast
Fractures, Bone, Impending Fracture
Retrospective Study on Clinical Performance and Safety Profile of Agile Nail
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the Agile intramedullary nail, used in pediatric patients according to the manufacturer Instructions For…
- Conditions
- Fractures, Bone, Impending Fracture, Deformity; Bone
- Trial name
- Agile (NCT06412939)
- Testing
- Agile Nail
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Orthofix s.r.l.
Cataract
Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
This clinical study will assess the safety and performance of Intensity SL IOL, 1 year post operation. The study will also evaluate the patient satisfaction of the implanted patients.
- Trial name
- Post-op (NCT06075459)
- Where
- Argentina
- Volunteers
- 60 people
- Sponsor
- Hanita Lenses
Aneurysm Abdominal, Peripheral Aneurysms
A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery…
- Conditions
- Aneurysm Abdominal, Peripheral Aneurysms, Arterial Disease Occlusive, Prothesis
- Trial name
- NCT05519826
- Testing
- Vascular surgery
- Where
- France
- Volunteers
- 373 people
- Sponsor
- Perouse Medical
Atrial Septal Defect, Patent Foramen Ovale
Post Market Registry of the CBSO
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD)…
- Trial name
- CBSO Registry (NCT04105595)
- Testing
- Septal defect closure
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- atHeart Medical
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
Dermatitis, Contact, Dermatitis
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters
The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.
- Conditions
- Dermatitis, Contact, Dermatitis, Dermatitis, Chronic, Dermatitis, Eczematous
- Trial name
- NCT07056569
- Testing
- 047_TD Dermatitis cream twice a day for 28 days
- Where
- 3 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Biokosmes Srl
Bowel Dysfunction
An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents
The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents.
- Trial name
- NCT06385249
- Testing
- Navina Mini
- Where
- Sweden
- Volunteers
- 27 people
- Sponsor
- Wellspect HealthCare
Zika Virus Infection
Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples.
- Trial name
- NCT03776903
- Testing
- ZIKV Detect™ 2.0 IgM Capture ELISA
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- InBios International, Inc.