Clinical trials: VALİDİTY
Cardiopulmonary Disease
Respiration Validation for CPM Device
This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized.
- Trial name
- NCT05445492
- Testing
- CPM Device
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Analog Device, Inc.
Healthy
Desaturation Validation of INVSENSOR00036
This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation.
- Trial name
- NCT04002960
- Testing
- INVSENSOR00036
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Pathology
Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
- Trial name
- NCT03992768
- Testing
- Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
- Where
- 3 sites in United States
- Volunteers
- 540 people
- Sponsor
- Hamamatsu Photonics K.K.
Dietary Habits
The PortionSize Smartphone App Pilot (PS Pilot)
The objective is to examine the preliminary validity, reliability and perceived participant satisfaction of the PortionSize app.
- Trial name
- PS Pilot (NCT04494971)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Pennington Biomedical Research Center
Computer + Fluency, Computer Only
Evaluation of a Computerized Opioid Overdose Prevention Program
Unintentional fatal drug overdose (OD) is now the 2nd leading cause of accidental death in the general population. Fatal OD from opioid analgesics specifically has increased over 400% between 1999 and 2008, and nonfatal overdose…
- Conditions
- Computer + Fluency, Computer Only, Treatment as Usual
- Trial name
- NCT02040077
- Testing
- Computer + Fluency, Computer Only, Treatment as Usual
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Johns Hopkins University
Infiltration of Peripheral IV Therapy
Milky Way Sensor Motion Validation
A single arm study of 20 adult volunteers to assess the safety and efficacy of the ivWatch sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
- Trial name
- NCT07228416
- Testing
- ivWatch Model 400
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Cardiovascular Disease
X-ray Dose Reduction Study for Endovascular Interventional Radiology
ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly.
- Trial name
- NCT01599741
- Testing
- Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology., Normal dose DSA with conventional X-ray imaging technology
- Where
- Netherlands
- Volunteers
- 51 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Streptococcus Agalactiae Infection
Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument.
- Trial name
- NCT02718157
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 4 sites in United States, Canada
- Volunteers
- 771 people
- Sponsor
- Meridian Bioscience, Inc.
Post Partum Hemorrhage, Blood Loss
Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial
This study will be a prospective cohort study. Patients who meet criteria for inclusion in the study will be approached for participation at same day of admission.
- Conditions
- Post Partum Hemorrhage, Blood Loss, Vaginal Bleeding, Vaginal Delivery
- Trial name
- ELUSIVE (NCT04277962)
- Testing
- Triton L and D system for estimation of blood loss at time of vaginal delivery
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Skin Cancer, Actinic Keratoses
Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
This study will evaluate the safety and effectiveness of Shade for the management of UV-induced skin complications and data collected from this study will be used to support the proposed indications for use.
- Conditions
- Skin Cancer, Actinic Keratoses, Ultraviolet-Induced Change in Normal Skin, Behavior, Health
- Trial name
- NCT03315286
- Testing
- SHADE Ultraviolet Sensor, Standard of care counseling
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- Weill Medical College of Cornell University
Rheumatoid Arthritis
Study for Validation of Standardized Questionnaires on Depression and Investigation of the Frequency of Depression in Rheumatoid Arthritis (RA) Participants
The purpose of this study is to validate standardized questionnaires on depression for RA and to investigate the frequency of depression with RA. The study will include 2 parts, VADERA I and VADERA II.
- Trial name
- NCT02485483
- Where
- 10 sites in Germany
- Volunteers
- 1,292 people
- Sponsor
- Hoffmann-La Roche
Lymphoma, Non-Hodgkin
Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies
Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade…
- Trial name
- RIT-II-001 (NCT01224821)
- Testing
- Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab
- Volunteers
- 47 people
- Sponsor
- GlaxoSmithKline
Dyspepsia
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia.
- Trial name
- NCT01248221
- Testing
- [13C]-Spirulina platensis and 99mTc sulfur colloid
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Heart Valve Disease
Validation of Naevia Medical in Valvulopathies
The study aims to validate naevia medical, a knowledge-based clinical decision support system (CDSS), for clinical benefit and safety in cases of cardiac valvulopathies.
- Trial name
- CDSS-Valve (NCT06392464)
- Testing
- Clinical decision support system (software)
- Where
- Spain
- Volunteers
- 106 people
- Sponsor
- Dilemma Solutions S.L.
Osteoarthritis, Knee
Validation of a Stress Device for the Knee
X-rays are the most frequently used imaging test when evaluating the knee for joint replacement. They are non-invasive, safe and cost effective.
- Trial name
- NCT02444663
- Testing
- Clinician Valgus, Clinician Varus, Device Valgus - 0 Newton
- Volunteers
- 9 people
- Sponsor
- Oxford University Hospitals NHS Trust
Coronary; Ischemic
Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve
This study will enroll patients who are referred for coronary angiography and require physiological assessment to see if the lesion can be treated as per the local standard of care. Approximately 92 participants will be enrolled.
- Trial name
- RFR (NCT03461705)
- Testing
- Volcano Verrata Pressure Wire, St. Jude Medical (SJM) Aeris Pressure Wire System
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Columbia University
Healthy
Metaplasticity Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change
The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by…
- Trial name
- NCT03304262
- Testing
- rTMS
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University of New Mexico
Healthy
Desaturation Validation of INVSENSOR00006
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer.
- Trial name
- NCT03435211
- Testing
- INVSENSOR00006
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Autism
Validation of Indiana's Early Evaluation Hub System
The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the…
- Trial name
- EAER21 (NCT06586788)
- Testing
- Eyelink Portable Duo, Integrated PCP Diagnosis and Eye-tracking Biomarker
- Where
- 7 sites in United States
- Volunteers
- 154 people
- Sponsor
- Indiana University
Predictive Validity of VLaHHS
Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator
Part 3 Phase III of this protocol is the interventional portion and is the reason why only this Part is registered and reported within this record.
- Trial name
- (VLaHHS) (NCT06974383)
- Testing
- Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center