Clinical trials: Reader Study
Breast Cancer
Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing
The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with…
- Trial name
- NCT03586583
- Testing
- FBP, ISR
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast Cancer
Imagio Feasibility Multi-Reader, Multi-Case Study
Controlled, blinded, multi-reader, multi-case study
- Trial name
- NCT03708393
- Testing
- Imagio (IUS+OA), Imagio Ultrasound, Mammography
- Where
- United States
- Volunteers
- 155 people
- Sponsor
- Seno Medical Instruments Inc.
Alzheimer Disease
A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 Positron Emission Tomography (PET) Scan Interpretation
This study will evaluate the performance of physician readers trained to read flortaucipir-PET (positron emission tomography) scans.
- Trial name
- NCT03901092
- Testing
- flortaucipir F 18
- Where
- United States
- Volunteers
- 242 people
- Sponsor
- Avid Radiopharmaceuticals
Alzheimer's Disease
The Feasibility of Florbetapir Quantitation in Europe
This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.
- Trial name
- NCT02107599
- Testing
- Florbetapir (18F)
- Where
- Netherlands
- Volunteers
- 96 people
- Sponsor
- Avid Radiopharmaceuticals
Breast Cancer
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study
The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.
- Trial name
- NCT03501693
- Testing
- DBT plus S-View, FFDM Alone
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast Cancer
Optoacoustic Images Versus Imagio® Ultrasound
The Imagio® Pivotal Study is intended to evaluate if the results observed in the previous Feasibility Study can be confirmed for pre-specified effectiveness endpoints.
- Trial name
- Reader-02 (NCT04030104)
- Testing
- Reader Study - Imagio Ultrasound, Reader Study Imagio Ultrasound + Optoacoustic Imaging, Mammography
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Seno Medical Instruments Inc.
Breast Cancer
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation…
- Trial name
- NCT02685566
- Testing
- FFDM Plus DBT, FFDM
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, 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.
Breast Cancer
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
- Trial name
- NCT03491917
- Testing
- DBT plus S-View, FFDM alone
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Chronic Constipation
Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.
- Trial name
- NCT01707667
- Testing
- prucalopride, PEG 3350
- Where
- 3 sites in United States, Belgium and 1 more
- Volunteers
- 13 people
- Sponsor
- Shire
Cognitive Impairment
A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe
This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe
- Trial name
- NCT04773015
- Where
- 10 sites in Austria, Finland and 3 more
- Volunteers
- 227 people
- Sponsor
- GE Healthcare
Pregnancy - Labor Monitoring
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® EMG Labor Monitor® (SureCALL®)to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter…
- Trial name
- NCT01282723
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Reproductive Research Technologies, LP