Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New York
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Rochester、New York、アメリカ、14642
- University of Rochester
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Predicate & Invest-GOS
Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
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Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector.
Multiple exams (head, chest, legs, etc) were made on the cadavers.
Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
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実験的：Predicate & Invest-CsI
Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
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Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector.
Multiple exams (head, chest, legs, etc) were made on the cadavers.
Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
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実験的：Predicate & Invest.-Cadavers GOS & CsI
Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers.
Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
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Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector.
Multiple exams (head, chest, legs, etc) were made on the cadavers.
Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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診断能力評価のラドレックス尺度
時間枠：最後のX線撮影から9週間後
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1-非診断 診断目的では受け入れられません。
臨床的に使用できる診断情報がほとんどまたはまったくない (例: 露出不足、システム障害、広範なモーション アーチファクト)。
ほとんどすべてのそのようなイメージングを繰り返す必要があります。
2-限定的 ある程度の技術的欠陥がある (モーション アーティファクト、体型/X 線透過率の低さ、または患者のポジショニングにより、一部の身体領域の視覚化が制限される可能性がありますが、診断目的には十分です)。
このタイプの検査に典型的なほど多くの診断情報はありませんが、おそらく十分です。
3-診断協力的な患者を画像化するときに日常的に期待される画質。
4-模範的 良好、診断目的に最も適しています。
エミュレートすべき例として役立つ画質。
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最後のX線撮影から9週間後
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Pair Preference Rating Scale
時間枠：9 weeks after last x-ray capture
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During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred.
Both the predicate and investigational images were randomly assigned to appear on the right or left monitors.
A spreadsheet was used for managing the data.
Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.
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9 weeks after last x-ray capture
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Susan Hobbs, MD、University of Rochester
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 6M2375
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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Radiationの臨床試験
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Basilea PharmaceuticaSidney Kimmel Comprehensive Cancer Center at Johns Hopkins終了しました