A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance,including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the Velieve U.S. device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device.
The use of the Velieve U.S. device will be evaluated for identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
調査の概要
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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Florida
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West Palm Beach、Florida、アメリカ、33409
- Comprehensive Clinical Trials, Llc
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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:
- Males and Females 18-80 years of age;
- Subjects who are healthy or:
Subjects with a medical condition that normally present with an abnormal concentration of Leukocytes, Nitrites and Blood: (examples of such conditions include the following):
- Urinary tract infection (UTI)
- Patients with suspected or known occult blood in urine
- Pregnant women
- Other relevant conditions
- Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion)
- Subject is capable and willing to provide informed consent;
- Subject has facility with both hands;
- Subject is capable and willing to adhere to the study procedures.
- Subject is familiar with the use of a smartphone
- Subject is capable of comprehending and following instructions in English
Exclusion Criteria:
- Subject has dementia.
- Subject has mental disorders.
- Subject cannot collect urine in a receptacle.
- Subject is visually impaired (cannot read the user manual).
- Any additional reason the study physician believes disqualifies the subject from participating in the study.
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：Velieve U.S.
Each participant will test their urine sample using the Velieve U.S. device
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The Velieve U.S. is a home use, in-vitro diagnostic (IVD) device.
The device is used for the semi-quantitative detection of blood and leukocytes, and the qualitative detection of nitrites in urine.
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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 |
時間枠 |
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Evaluation of the % agreement of the Velieve U.S., tested by the lay user, as compared to a comparator device, tested by a professional user.
時間枠：11 months
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11 months
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二次結果の測定
結果測定 |
時間枠 |
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Evaluation of the Velieve U.S. usability success rate, by potential lay users under actual use conditions.
時間枠：11 months
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11 months
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Velieve U.S.の臨床試験
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Boston UniversityNational Institute of Mental Health (NIMH)募集