Clinical trials: Accuracy
Bioelectrical Impedance Measurement of Healthy Adults
Comparing Medical Body Composition Analyzer Seca mBCA 555 With Seca mBCA 515
The mBCA 515 was compared to the gold standard methods MRI, DXA, ADP, D2O- and NaBr-dilution in previous clinical investigations (BCA-01, BCA-02, BCA-20) to generate prediction equations for calculating body composition (FFM…
- Trial name
- NCT04030416
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Seca GmbH & Co. Kg.
Hydrocephalus, Normal Pressure Hydrocephalus
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
The purpose of this study is to determine the agreement rate between the CODMAN Valve Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in order to support an alternative to X-ray confirmation…
- Trial name
- NCT00196196
- Testing
- Codman VPV System
- Where
- 8 sites in United States
- Volunteers
- 274 people
- Sponsor
- Codman & Shurtleff
Hypoxia
Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO18)
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling.
- Trial name
- NCT05807464
- Testing
- Pulse Oximeter
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Nihon Kohden
Healthy
Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor
In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers.
- Trial name
- NCT03125005
- Testing
- Rainbow Universal Pulse Oximeter Sensor
- Where
- 2 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Diabetes Mellitus, Diabetes Mellitus, Type 1
PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180…
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- PROMISE (NCT03808376)
- Testing
- Continuous Glucose Monitoring System
- Where
- 8 sites in United States
- Volunteers
- 208 people
- Sponsor
- Senseonics, Inc.
Accuracy of Measurement of Respiration Rate
Reassure Spot Respiration Rate Accuracy Compared to SOMNOScreen
A trial conducted within the company with a new non-contact respiration rate (RR) sensor. The device was compared for accuracy in RR measurement with a cleared device, the SOMNOScreen Easy, which uses chest effort bands.
- Trial name
- NCT02740504
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ResMed
Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
Postmarket Clinical Follow-up Study to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M (SOMBRERO)
This study is a post market clinical follow up study performed to confirm the performance of BrOxy M pulse oximeter in comparison with a reference, CE marked, pulse oximeter equipment in a controlled desaturation study over a…
- Trial name
- SOMBRERO (NCT04810221)
- Testing
- Controlled desaturation study
- Where
- Italy
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Life Meter srl
Healthy
Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors
In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously.
- Trial name
- NCT03124966
- Testing
- Pulse Oximeter sensor
- Where
- 2 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Healthy
Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (RD DCI)
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes.
- Trial name
- NCT03124797
- Testing
- RD DCI Sensor
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Device Latency
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02404532)
- Testing
- MIND1 System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Lower Urinary Tract Symptoms
Portable Pves Study
A comparative study will be conducted and the patient will undergo a conventional urodynamic study. In order to successfully determine if the Peritron+ is capturing vesical pressure measurements consistent with conventional…
- Trial name
- NCT02673944
- Testing
- Peritron+
- Volunteers
- 10 people
- Sponsor
- Laborie Medical Technologies Inc.
Prostate Cancer
A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer.
- Trial name
- NCT01667536
- Testing
- Drug: 99mTc-MIP-1404
- Where
- 35 sites in United States, Belgium and 6 more
- Volunteers
- 105 people
- Sponsor
- Molecular Insight Pharmaceuticals, Inc.
Myopia, Hyperopia
Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.
- Trial name
- NCT02575911
- Testing
- Femtosecond Laser System, LASIK surgery
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Alcon Research
Aspiration Pneumonia
Functionality and Accuracy of the smART System in Real-Life ICU Settings
Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Jefferson study site there were 8 participants and in the Sheba study site (identifier…
- Trial name
- NCT03198988
- Testing
- smART Feeding Tube System
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- ART Medical Ltd.
Healthy
Accuracy of Noninvasive Rainbow Adhesive R1 Pulse Oximeter Sensor
In this study, the concentration of hemoglobin will be measured using a noninvasive pulse oximeter sensor and compared with the hemoglobin value from a blood sample of the volunteer.
- Trial name
- NCT03134313
- Testing
- Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Type 1 Diabetes, Type 2 Diabetes
Adult Accuracy Study of the Enlite 3 Glucose Sensor
The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1…
- Trial name
- E3 (NCT02246582)
- Testing
- Enlite 3, Guardian Mobile App, 640G Insulin Pump
- Where
- 6 sites in United States
- Volunteers
- 118 people
- Sponsor
- Medtronic MiniMed, Inc.
Endovascular Procedures
Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events
To evaluate the safety and accuracy of the Saranas EBBMS for the detection of access site related internal bleeding events during large-bore endovascular procedures.
- Trial name
- NCT03621202
- Testing
- Saranas Early Bird Bleed Monitoring System (EBBMS)
- Where
- 5 sites in United States
- Volunteers
- 66 people
- Sponsor
- Saranas, Inc.
Breast Cancer
Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.
- Trial name
- NCT02511730
- Testing
- FFDM Plus DBT, FFDM
- Where
- 4 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Osteo Arthritis Knee, Osteoarthritis
Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty
The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual…
- Trial name
- NCT04730271
- Testing
- Total Knee Replacement
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- DePuy Orthopaedics
Diabetes Mellitus
Evaluation of the Accuracy of an Implanted Glucose Sensor
The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The…
- Trial name
- PRECISEII (NCT02647905)
- Testing
- Continuous Glucose Monitoring System
- Where
- 9 sites in United States
- Volunteers
- 90 people
- Sponsor
- Senseonics, Inc.