Clinical trials: Validation Studies
Sweat Analysis
NBA G-League Sweat Testing Study: Validity of the Gx Sweat Patch in Measuring Sweating Rate and Sweat Chloride Concentration During On-court Training With Basketball Players
To determine the validity of the Gx Sweat Patch in measuring sweating rate and sweat chloride concentration during moderate-high intensity practice against well-established reference methods in field conditions with basketball…
- Trial name
- NCT04679532
- Testing
- Gx sweat patch, Reference sweat patch
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Decision Support Systems, Anemia
Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care
Anemia need to be diagnosed and treated, following several guidelines. However, the complexity of these recommendations leads to low compliance and to unnecessary and harmful per- and postoperative blood transfusion.
- Trial name
- iAnemia (NCT04484233)
- Testing
- iAnemia Decision Support System
- Volunteers
- 1,000 people
- Sponsor
- Intelligence Anesthesia
Obstructive Sleep Apnea
TipTraQ Home Sleep Test Validation Study, Duke
A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional…
- Trial name
- NCT06351878
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Chronic Respiratory Failure, Acute Respiratory Failure
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
This study evaluates EMILY.AI, an investigational (non-CE-marked) smart oxygen valve that automatically adjusts the oxygen flow delivered to a patient, second by second, according to oxygen saturation (SpO2), heart rate and…
- Conditions
- Chronic Respiratory Failure, Acute Respiratory Failure, Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure
- Trial name
- NCT06952816
- Testing
- Emily.AI, Manual oxygen titration
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Aether Tech S.L.
Colorectal Cancer
First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer
The CORRECT - MRD I study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for up to 5 years for recurrence.
- Trial name
- MRD (NCT06398743)
- Testing
- MRD
- Where
- 22 sites in Israel, Italy and 3 more
- Volunteers
- 416 people
- Sponsor
- Exact Sciences Corporation
Transthyretin Cardiac Amyloidosis
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
CONCERTO is a retrospective, observational, multicentric and single-arm study to perform an external validation of the cloud-based and AI-powered electrocardiogram (ECG) analysis platform, named Willem™, to detect Transthyretin…
- Trial name
- CONCERTO (NCT06978660)
- Where
- 8 sites in United States, France and 3 more
- Volunteers
- 2,200 people
- Sponsor
- Idoven 1903 S.L.
Nasal Valve Collapse
Validity Study of a Nasal Valve Implant
The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse.
- Trial name
- NCT00837525
- Testing
- nasal valve implant
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Nasoform, LLC
Fever, Respiratory Tract Infections
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients.
- Conditions
- Fever, Respiratory Tract Infections, Urinary Tract Infections, Gastroenteritis
- Trial name
- PATHFINDER (NCT01911143)
- Where
- 2 sites in Israel
- Volunteers
- 600 people
- Sponsor
- MeMed Diagnostics Ltd.
Hepatocellular Carcinoma
Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma
Most hepatocellular carcinoma (HCC) cases were at advanced stage when diagnosis established. This study is intended to establish a clinical diagnostic model GAMAD for early-stage HCC and evaluate the diagnostic efficiency the…
- Trial name
- NCT05626985
- Testing
- GAMAD
- Where
- 3 sites in China
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Singlera Genomics Inc.
Cardiovascular Disease
Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization
The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device to measure regional oxygen saturation in a cohort of children with cardiovascular disease undergoing cardiac catheterization.
- Trial name
- NCT00939224
- Testing
- Model 7600 Regional Oximeter System
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Nonin Medical, Inc
Sepsis, Infection
CV-SQuISH-ED: Clinical Validation Study
This is a study to evaluate the diagnostic performance of the investigational Cytovale System \& IntelliSep Test as a diagnostic marker of sepsis in a population of patients presenting to the emergency department with signs or…
- Trial name
- NCT04933760
- Testing
- Cytovale IntellipSep test
- Where
- 4 sites in United States
- Volunteers
- 599 people
- Sponsor
- Cytovale, Inc.
Laparoscopic Gynecological Surgery
Human Factors Actual-Use Clinical Protocol
The purpose of this study is to confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use by representative users, use, and use environments as required for regulatory agency…
- Trial name
- CONTAIN (NCT04799210)
- Testing
- Eximis CS (Contained Segmentation) System
- Where
- 7 sites in United States
- Volunteers
- 3 people
- Sponsor
- Eximis Surgical
Preeclampsia (PE)
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Preeclampsia (PE) is a major obstetric complication with severe short- and long-term consequences for both mother and fetus. Early detection is critical to mitigate PE-related morbidity and mortality.
- Trial name
- iPregnostic (NCT06716242)
- Testing
- Peripheral blood collection
- Where
- 11 sites in Spain
- Volunteers
- 7,473 people
- Sponsor
- iPremom
Pancreatic Cancer
EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients
Bluestar Genomics has developed a non-invasive test that aids in the qualitative detection of occult pancreatic cancer in patients with new onset type II diabetes (NOD) who are 50 years old or older.
- Trial name
- NCT05188573
- Testing
- Early detection pancreatic cancer test, Early detection pancreatic cancer test and MRI Imaging
- Where
- United States
- Sponsor
- ClearNote Health
Metastatic Colorectal Cancer, RAS Wild-type
Validation of a New Prognostic Score for Adult Patients With RAS Wild-type mCRC Treated With Vectibix® and FOLFIRI or FOLFOX in First Line (VALIDATE)
A safety and efficacy study of first line therapy with Vectibix® in combination with FOLFIRI or FOLFOX to validate a prognostic score in adult patients with RAS wild-type metastatic colorectal cancer in a real world setting…
- Trial name
- VALIDATE (NCT03043950)
- Testing
- Panitumumab
- Where
- Germany
- Volunteers
- 647 people
- Sponsor
- iOMEDICO AG