Clinical trials: Device Performance
Visual Function
A Performance Study Comparing the EyeMirage (Test Device) to Standard of Care (Reference Device) in Patients 18 to 65 Years of Age Undergoing Standard Eye Examinations Such as Visual Acuity, Visual Field, Color Vision, and Self-Paced Saccade for Various Conditions
This study will assess the effectiveness and accuracy of results of a new device for eye function testing. This will be done by comparing results of four eye tests that are done through the current standard used in eye clinics…
- Trial name
- NCT06908967
- Testing
- EyeMirage device
- Where
- 4 sites in Canada
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Neuroptek Corporation Inc.
Injections, Intradermal
Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.
The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery devices can safely and precisely inject liquid into the intradermal layer of the skin in three different injection locations
- Trial name
- NCT01943110
- Testing
- ID adapter (autodisable), ID adapter (side load)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- PATH
Refractive Errors, Astigmatism
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.
- Trial name
- NCT03929588
- Testing
- Hand-held device supported by a mobile application, Phoropter, Autorefractor
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
Diabetes Mellitus, Chronic Kidney Diseases
Cardiometabolic Devices Accuracy Study
With the rise of cardiovascular diseases (CVD) and diabetes, the global disease burden is shifting towards non-communicable diseases (NCDs).
- Conditions
- Diabetes Mellitus, Chronic Kidney Diseases, Hyperlipidemias
- Trial name
- NCT05257564
- Testing
- Determine the accuracy of quantitative measurements of GLU, HbA1c,CHOL and CRE with POC devices compared to a laboratory reference method (Roche)
- Where
- Nepal
- Volunteers
- 359 people, healthy volunteers welcome
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Oropharyngeal Leak Pressure, Supraglottic Airway
A Randomised Controlled Trial to Compare Two Supraglottic Airway Devices (Ambu AuraGain vs Air Q-3) in Terms of Performance Characteristics.
A supraglottic airway device (SAD) functions as a temporary device to maintain the patency of airway during the administration of anaesthesia.
- Conditions
- Oropharyngeal Leak Pressure, Supraglottic Airway, Elective Surgery, General Anaesthesia
- Trial name
- NCT06914453
- Testing
- Air Q-3 Supraglottic Airway Device, Ambu AuraGain Supraglottic Airway Device
- Where
- Malaysia
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of Malaya
No Disease or Condition is Being Studied
Evaluation of the Performance and Safety of VACUSERA® PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma
Study Design After the eligibility assessment during screening and obtaining a written informed consent form, the volunteers' demographic information and medical history will be recorded.
- Trial name
- PRP (NCT07041918)
- Testing
- The study is entirely designed to analyze product performance (analyze only results from whole blood and derived from the PRP tubes), and no interventions will be performed.
- Where
- Turkey (Türkiye)
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Disera Tıbbi Cihazlar Lojistik Sanayi ve Ticaret A.Ş
Myopia
Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users
The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices…
- Trial name
- PUG (NCT04201639)
- Testing
- Verofilcon A contact lenses
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Waterloo
Port a Cath
Structured Training on Oncology Nurses' Performance Related Port A Cath Device
evaluate the effect of structured simulation-based training on oncology nurses' performance regarding port A cath device.
- Trial name
- NCT05774301
- Testing
- simulation-based training
- Where
- Egypt
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mansoura University
Academic Performance, Anxiety
Mindful Minds: Mindfulness-Based Neurofeedback for Underrepresented College Students
The study examines the efficacy of a mindfulness-based neurofeedback protocol designed to improve academic performance and reduce performance anxiety in racial and ethnic minority college students.
- Trial name
- NCT06784934
- Testing
- NeuroSky Mindfulness-Based Neurofeedback
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Florida International University
Stoma Ileostomy
Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a Stoma
The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to follow performance and safety of the newly marketed SenSura® Mio Baby device in a real-life setting.
- Trial name
- NCT03929978
- Volunteers
- healthy volunteers welcome
- Sponsor
- Coloplast A/S
COVID-19 Virus Infection, COVID-19
Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC
A rapid point of care test for the detection of virus particles will be compared to the FDA approved EUA RT-PCR detection standard.
- Conditions
- COVID-19 Virus Infection, COVID-19, Coronavirus Disease-19, COVID-19 Pandemic
- Trial name
- NCT05514691
- Testing
- iStatis COVID-19 Ag Rapid Test, "COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America ("Labcorp")
- Where
- 2 sites in United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Hypertension
OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device
This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G1-US for up to 7…
- Trial name
- OBPM_PANDA2026 (NCT07507903)
- Testing
- Device under test evaluation against references
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Aktiia SA
Breast Cancer Screening
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening
This is a single-center, pilot study being conducted to evaluate the safety and performance of the investigational device (MUST) in detecting malignant lesions in breast tissue.
- Trial name
- NCT04102722
- Testing
- MUST device
- Where
- United States
- Volunteers
- 1,333 people, healthy volunteers welcome
- Sponsor
- Transonic Imaging, Inc.
Injections, Intradermal
Performance and Safety Evaluation of an Intradermal Delivery Device
The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.
- Trial name
- NCT01359111
- Testing
- PATH ID Adapter
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- PATH
Contraception
Impact and Performance of Institutionalizing Immediate Post-partum IUD Services
Studying the impact and performance of institutionalizing immediate post-partum IUD services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Tanzania, and Nepal.
- Trial name
- NCT02718222
- Testing
- Post-partum IUD
- Where
- 3 sites in Nepal, Sri Lanka and 1 more
- Volunteers
- 140,258 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Keratosis, Actinic, Actinic Lesion
A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin
In this clinical one-site investigation the performance and safety of a skin preparation device will be evaluated for removing hyperkeratotic skin prior to further medical treatment.
- Conditions
- Keratosis, Actinic, Actinic Lesion, Solar Keratosis/Sunburn, Hyperkeratosis
- Trial name
- NCT05356572
- Testing
- Investigational Skin Preparation Device, GMDN 47102 / Electrode Skin Abrasive Pad, UMDNS 13-230 / Biopsy punch (Dermal Curette)
- Where
- Finland
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Mirka Ltd
Arrhythmia
Clinical Performance Evaluation of the Hativ P30
Hativ P30 is intended to record, store, and transfer one-and two-channel ECG rhythms, and analyze them based on an artificial intelligence (AI) algorithm. In single channel mode, Hativ P30 can record lead-I.
- Trial name
- NCT06713226
- Testing
- Hativ P30 and 12-lead ECG comparator device
- Volunteers
- healthy volunteers welcome
- Sponsor
- VUNO Inc.
Hypertension, Blood Pressure
Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation
This study with N = 225 participants (1 cohort of a minimum of 85 and maximum of 140 participants, and an additional cohort with 85 participants) over 9 visits has been designed to assess the accuracy of Aktiia.product-us…
- Conditions
- Hypertension, Blood Pressure, Heart Rate
- Trial name
- NCT05236348
- Testing
- Aktiia.product-us
- Where
- Switzerland
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Aktiia SA
Healthy Volunteers, Adolescent
PureWick™ Adolescent Study
A prospective, uncontrolled, open-label healthy volunteer study to assess the performance of the PureWick Male and PureWick Flex Female external catheter devices in adolescents
- Trial name
- NCT06631313
- Testing
- PureWick System
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Hypertension
A Multi-centre Study Evaluating the Performance and Acceptance of the Hilo Band Cuffless Blood Pressure Medical Device in the Normo-, Hypo- and Hyper-tensive Young Population: a Comparison With the 24-h Ambulatory Blood Pressure Monitoring (ABPM)
Hypertension is one of the main risk factors for the onset of cardiovascular diseases. It is often silent, and most individuals are unaware they have it.
- Trial name
- IPSI-HYPE-001 (NCT07072689)
- Where
- 2 sites in Switzerland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Simonetti Giacomo