Clinical trials: Accuracy of Tissue Diagnosis
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.
Breast Cancer
Case Collection Study to Support Digital Mammography Image Software Change
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.
- Trial name
- LIP2SIP (NCT00756496)
- Testing
- Mammography screening and diagnosis
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions USA - CSG
Breast Cancer
Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening
The purpose of this study is to test an innovative MRI breast cancer screening method in women with mammographically dense breasts as well as other women with moderately increased cancer risk.
- Trial name
- NCT04877912
- Testing
- MRI Abbreviated Scan, Abbreviated MRI Scan
- Where
- United States
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Breast Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)
The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results…
- Trial name
- ADAPT (NCT02324205)
- Testing
- DBT and FFDM
- Where
- 3 sites in United States, France
- Volunteers
- 196 people
- Sponsor
- GE Healthcare
Post-endoscopic Mucosal Resection of Colon Polyps
Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods
The purpose of this study is to compare the accuracy of using different endoscopic imaging technique (white light, white light with near focus, narrow band imaging (NBI), NBI with near focus) for detection of residual neoplastic…
- Trial name
- NCT02668198
- Testing
- Olympus CF190 Colonoscope High definition white light, Olympus CF190 Colonoscope White light with near focus, Olympus CF190 Colonoscope Narrow band imaging
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Michael Wallace
Respiratory Disease
Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment
Patients with lung disease who report breathlessness on exertion are often referred for a 6MWT. Due to the nature of the 6MWT (hereon referred to as a Max-6MWT), patients are required to walk as far as they can in 6 minutes.
- Trial name
- NCT05630092
- Testing
- Maximal 6-minute Walk Test (Max_6MWT), Normal speed 6-minute Walk Test (Nor_6MWT)
- Where
- United Kingdom
- Volunteers
- 93 people
- Sponsor
- Hampshire Hospitals NHS Foundation Trust
Breast Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology…
- Trial name
- ADAPT-ENRICH (NCT02540083)
- Testing
- DBT and FFDM
- Where
- 2 sites in United States
- Volunteers
- 94 people
- Sponsor
- GE Healthcare
Breast Cancer
A Study to Evaluate the Accuracy of a Breast Cancer Locator (BCL) in Patients With Palpable Cancers
In this study, the investigators will enroll women with palpable cancers to assess the accuracy of the Breast Cancer Locator (BCL) and the concomitant procedure as a vehicle to optimize and validate the approach in such surgical…
- Trial name
- NCT02550210
- Testing
- Breast Cancer Locator (BCL)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Accuracy of Tissue Diagnosis, Bile Duct Stricture
Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods
The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis when compared to standard biopsy techniques.
- Conditions
- Accuracy of Tissue Diagnosis, Bile Duct Stricture, Pancreatic Duct Stricture
- Trial name
- NCT01227382
- Testing
- ERCP with cholangiopancreatoscopy
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Florida
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
Sunburn, Erythema, Sun Protection
UV Exposure Assessed With Wearable Sensor and Sun Protection
The goal is to prevent ultraviolet light (UV) overexposure by providing consumers with relevant, easy-to-access, specifically actionable information.
- Trial name
- NCT03344796
- Testing
- Goal attainment
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Diabetic Foot, Peripheral Arterial Disease
TEsting for Arterial Disease in Diabetes (TrEAD) Study
This study will focus on determining; How accurate the test is in detecting poor circulation How it's accuracy compares to other commonly used tests, and Whether test results are linked to the chance of ulcer healing or…
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases
- Trial name
- NCT04058626
- Testing
- Transcutaneous pressure of oxygen (TcPO2), Toe Brachial Pressure Index (TBPI), Podiatry Ankle Duplex scan (PAD-scan)
- Where
- 2 sites in United Kingdom
- Volunteers
- 305 people
- Sponsor
- Imperial College Healthcare NHS Trust
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.
Malignant Melanoma
Diagnostic Precision of the AI Tool Dermalyzer to Identify Malignant Melanomas in Subjects Seeking Primary Care for Melanoma-suspected Cutaneous Lesions
Dermalyzer is a device intended to be used as a decision support system for assessing cutaneous lesions suspected of being melanomas.
- Trial name
- AI-DSMM (NCT05172232)
- Testing
- Dermalyzer
- Where
- 3 sites in Sweden
- Volunteers
- 231 people
- Sponsor
- Linkoeping University
Lichen Sclerosus, Lichen Planus
Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis
The objective of the study was to determine sensitivity, specificity and diagnostic accuracy of "Three Rings Vulvoscopy" for detection of vulvar dermatosis using histopathology as the reference standard.
- Conditions
- Lichen Sclerosus, Lichen Planus, Lichen Simplex Chronicus, Vulvodynia
- Trial name
- DATRIV (NCT02732145)
- Testing
- "Three Rings Vulvoscopy" (TRIV), Histopathology
- Where
- Croatia
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- Ginekološka Poliklinika Dr. Vesna Harni
Breast Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from asymptomatic women undergoing screening mammography.
- Conditions
- Breast Cancer, Tumors, Breast, Cancer Screening
- Trial name
- ADAPT (NCT02306265)
- Testing
- FFDM, DBT
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- GE Healthcare
Breast Cancer
A Multi-Reader Multi-Case Pivotal Trial
The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.
- Trial name
- NCT02692209
- Testing
- FFDM Plus DBT, FFDM Alone
- Where
- 5 sites in United States
- Volunteers
- 298 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.
Low Blood Pressure, Normal Blood Pressure
Clinical Trial of H2-BP Electronic Sphygmomanometer
The study compares H2-BP, a wristband blood pressure monitor, with an auscultatory sphygmomanometer. Both devices are used on the same arm.
- Conditions
- Low Blood Pressure, Normal Blood Pressure, Prehypertension, Hypertension
- Trial name
- NCT06491433
- Testing
- H2-BP
- Where
- South Korea
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Gangnam Severance Hospital
Spinal Tumor
A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
The goal of the first part of this clinical research study is to learn how to deliver more accurate radiation treatment of tumors in the spine.
- Trial name
- NCT01624220
- Testing
- Spinal SBRT (Standard Dose), Spinal SBRT (Higher Dose), Gold Seed Implantation
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- M.D. Anderson Cancer Center