Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Radlex Scale for Diagnostic Capability Ratings
研究概览
简要总结
The purpose of this clinical study is to evaluate the imaging performance of the Carestream PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the "investigational devices") as compared to the currently marketed Carestream DRX-1 Detector (referred to as the "predicate device"). Both detectors are flat panel digital imaging devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new detectors in the US. The study was designed in accordance with the FDA Guidance titled "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices", issued on August 6, 1999.
详细描述
The purpose of this clinical study is to evaluate the imaging performance of the investigational devices as compared to the currently marketed predicate device. The evaluation will consist primarily of comparing the diagnostic image quality of pediatric and adult cadaver studies and adult live human subject studies acquired under the same exposure technique.
Under the same position and radiological technique, pediatric and adult cadaver studies, and adult live human subject studies, using double-exposed images will be acquired to evaluate the diagnostic image quality of the investigational device versus the predicate device. Target images will be assembled and reviewed in a side-by-side Comparative Evaluation to statistically confirm the findings of this evaluation.
The live human subject portion of this study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which they will have two (2) x-rays taken.The first x-ray will follow standard technique using the cleared predicate detector currently in use at the site. Following the first x-ray, we will take one additional x-ray of the same part of the body with one (1) of the investigational detectors. The x-ray from the investigational detector will not be used to diagnose.
If the x-ray obtained by the standard DR x-ray detector shows any unforeseen, unusual or abnormal findings, these findings will be communicated to the subject and their doctor by USPS mail.
Reason for Observational Study Type: There are three (3) physical detectors being used in this study. Each detector is 35 centimeters by 43 centimeters. None of the subjects will given a detector. All subjects are healthy volunteers recruited by flyer. All subjects will be imaged with the same predicate detector and one (1) of the investigational detectors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •X-ray images of nearly identical positioning and exposure
- •No visible image artifacts
- •Subject 21 years or older
- •Subject has provided informed consent
- •Subject is in good general health (is able to be still to reduce the potential of motion in the images)
- •Subject is able to stand for two (2) x-rays
排除标准
- •Images that are not clinically acceptable for clinical radiographic reading as determined by the Principal Investigator.
- •Subject is pregnant or suspicious of being pregnant
- •Subject not able or willing to provide Informed Consent, or consent is withdrawn
- •Not able to collect all required case information
- •Subject has a history of high radiation exposure:
- •Subject has undergone radiation therapy
- •Subject has had two (2) or more CT scans within the past year
结局指标
主要结局
Radlex Scale for Diagnostic Capability Ratings
时间窗: 9 weeks after last x-ray capture
1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
次要结局
- Pair Preference Rating Scale(9 weeks after last x-ray capture)