Clinical trials: Validity
Device Validation of In-vivo Performance
An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.
- Trial name
- NCT05239455
- Testing
- Reveos® Automated Blood Processing System
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Child
Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina
This study aims to evaluate the effectiveness of a Cloak Shape sham Pediatric Tuina device which can be applied in randomized controlled trials for Pediatric Tuina research.
- Trial name
- NCT03474172
- Testing
- Cloak Shape Device for Genuine Tuina
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Guangzhou University of Traditional Chinese Medicine
Healthy
Validation of a Digital Twin Performing Strength Training
Background: Muscular strength training interventions have long been a cornerstone in the prevention, non-surgical management and rehabilitation of the entire spectrum of musculoskeletal injuries and diseases.
- Trial name
- NCT04849923
- Testing
- Strength training session
- Where
- Switzerland
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Silvio Lorenzetti
Pancreatic Cancer
GTX-RT in Borderline Resectable Pancreatic Cancer
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at participant's tumor followed by more…
- Trial name
- NCT01754623
- Testing
- Capecitabine, Gemcitabine, Docetaxel
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Spinal Cord Injuries
Extending Veteran Participation in the Validation of the SCI-QOL/CAT
The field of spinal cord injury rehabilitation medicine lacks a reliable, patient reported, health-related quality of life measurement tool.
- Trial name
- NCT01238549
- Where
- 2 sites in United States
- Volunteers
- 284 people
- Sponsor
- VA Office of Research and Development
Deglutition Disorders
Wearable Monitoring Systems for Swallowing Function and Disorders
Wearable tele-rehabilitation technology allows for the efficient provision of rehabilitation services from a distance, facilitating tele-management of many disorders.
- Trial name
- NCT04243577
- Testing
- Tele-EaT Sensors, Conventional Sensors
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Purdue University
Coronary Artery Disease
Validation of a Vital Signs Monitoring Wristband
Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home…
- Trial name
- MULTI-VITAL (NCT05566886)
- Testing
- Continuous measurement of photoplethysmography at the wrist
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Corsano Health B.V.
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
Pathologic Processes
Pivotal Study for Validation of Philips Dx (PDx)
The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.
- Trial name
- NCT02529137
- Where
- 4 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Philips Digital & Computational Pathology
Disorder of Consciousness, Traumatic Brain Injury
Validity and Feasibility of the CRSR-FAST
The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings.
- Trial name
- CRSR-FAST (NCT03549572)
- Testing
- Coma Recovery Scale-Revised
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Massachusetts General Hospital
Cardiac Arrhythmia
Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II
This trial assesses the wear performance of the Zio monitor, a long-term continuous ambulatory patch ECG monitor, in a representative population by evaluating (1) the wear duration (up to 30 days) of the device, (2) the…
- Trial name
- NCT07205367
- Testing
- Zio Monitor
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- iRhythm Technologies, Inc.
Surgery
Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI
The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices.
- Trial name
- NCT02841397
- Testing
- Masimo Pulse CO-Oximeter
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Masimo Corporation
Prostate Cancer, Prostate Cancer, Familial
Clinical Validity and Utility of Genomic-targeted Chemoprevention of PCa: Aim 4a
This study was designed to compare the efficacy, perception, decision making, and cost-effectiveness of genomic and non-genomic approaches for risk assessment of prostate cancer and for chemoprevention of prostate cancer.
- Conditions
- Prostate Cancer, Prostate Cancer, Familial, Hereditary Prostate Cancer
- Trial name
- NCT02381015
- Testing
- Genetic Risk Score: Number Format, Genetic Risk Score: Number + Pictograph, Family History: Number Format
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Pathology
Instrument Precision Study for Validation of Philips Dx
The objective of this study is to evaluate precision of the Philips Dx system.
- Trial name
- NCT02699970
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Gonarthrosis
Validation of a Knee Brace for Gonarthrosis
A study about the effects of different fastening systems for knee braces on comfort, ease of installation and treatment efficacy both physical and psychological.
- Trial name
- NCT05814471
- Testing
- Cable fastening system and 3d printed straps(14 days), Velcro straps system(14 days), Adjustment period(Velcro-14 days)
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- TOPMED
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer
This phase II trial studies how well docetaxel or paclitaxel work in reducing chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT04001829
- Testing
- Docetaxel, Paclitaxel, Quality-of-Life Assessment
- Where
- 482 sites in United States
- Volunteers
- 249 people
- Sponsor
- ECOG-ACRIN Cancer Research Group
Opioid Use Disorder
Assessment of Methadone and Buprenorphine in Interstitial Fluid
The purpose of this research is to determine if common medications for opioid use disorder (i.e., buprenorphine/naloxone, buprenorphine, methadone) and their metabolites (norbuprenorphine [a metabolite of buprenorphine]…
- Trial name
- NCT05546229
- Testing
- Microneedle based interstitial fluid collection
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Cari Health Inc.
Infiltration of Peripheral IV Therapy
ivWatch Sensor: Device Validation for Infiltrated Tissues
A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
- Trial name
- NCT04064229
- Testing
- ivWatch Model 400 with SmartTouch Sensor, ivWatch Model 400 with Fiber Optic Sensor
- Where
- United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Refractive Errors
Clinical Validation of DACP Digital Design
The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.
- Trial name
- NCT03567005
- Testing
- Nelfilcon A digital contact lenses, Nelfilcon A contact lenses
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Alcon Research
Validation Studies
d13C Added Sugar Intake Biomarker: Determining Validity in Children
Added sugars (AS) constitute a significant source (~ 16%) of the total daily calories consumed by youth. The role of AS in health is contentious, and the reliance on self-reported dietary data is an often-cited flaw in existing…
- Trial name
- NCT02455388
- Testing
- High added sugar diet, Low added sugar diet
- Where
- United States
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Virginia Polytechnic Institute and State University