ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients (SCNPH)
A Double- Blinded Comparison of the Accuracy of ShuntCheck, a Non-Invasive Device, to Radionuclide Shunt Patency Test in Evaluating Shunt Function in Patients With Adult Hydrocephalus With Possible Shunt Obstruction
調査の概要
詳細な説明
The primary objective is to demonstrate that the accuracy of SC and SC+MP for determining whether a VP shunt is patent or obstructed is statistically no different than the accuracy of the accepted standard test, radionuclide shunt patency study, when performed simultaneously.
A secondary objective is to determine SC and SC+MP results in the presence of possible partial obstruction, which defined as subjects with radionuclide clearance measured by T1/2 of 8 to 10 minutes.
A secondary objective is to compare ShuntCheck flow rate results to simultaneous radionuclide clearance as measured by T1/2. A secondary objective is to demonstrate that ShuntCheck flow rate results are statistically equivalent to simultaneous radionuclide clearance measured by T1/2
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21215
- Sinai Hospital of Baltimore, LifeBridge Health
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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:
- Adult men or women > 35 years of age;
- Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent;
- Possess a shunt placed for AH;
- A radionuclide shunt patency study has been ordered because of suspected shunt obstruction
- Subject is willing and able to return to the treating physician for evaluation of the outcome of the shunt patency study
Exclusion Criteria:
- Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
- ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
- Presence of an interfering open wound or edema over any portion of the VP shunt;
- Subject is unwilling or unable to return to the treating physician for the SPS and ShuntCheck testing.
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Radionuclide SPS
Radionuclide Shunt Patency Study
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Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing
他の名前：
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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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Sensitivity and specificity of ShuntCheck vs SPS
時間枠：Day 1
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The primary efficacy objective is the sensitivity and specificity of the ShuntCheck test. The performance of ShuntCheck test will be compared to the radionuclide scanning done on the day of ShuntCheck administration. Primary efficacy of the SC and SC+MP test will be determined by comparing SC and SC+MP performance to results of radionuclide scanning according to a standard 2 x 2 table, with a Positive test result defined as evidence of shunt obstruction. |
Day 1
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Michael A Williams, MD、Sinai Hospital of Baltimore, LifeBridge Health
- スタディチェア：Sherman C Stein, MD、NeuroDx Development
- スタディディレクター：Marek Swoboda, PhD、NeuroDx Development
出版物と役立つリンク
便利なリンク
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
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。
ShuntCheck testの臨床試験
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PATHUnited States Agency for International Development (USAID); Kintampo Health Research Centre,...完了
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Wageningen University完了
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Centre Georges Francois Leclerc積極的、募集していないステージ IV の非小細胞気管支肺癌であり、現在のフランスの推奨に従って第一選択治療の恩恵を受けるフランス