Pivot Breath Sensor Performance Study
A clinical study enrolling 70 subjects to:
- evaluate the user performance of the Pivot Breath Sensor
- compare measurements from the Pivot Breath Sensor to a similar device
- assess user documentation comprehension
- obtain feedback on the Pivot Breath Sensor via rating scales. No medical decisions will be made related to test results.
調査の概要
状態
詳細な説明
The objectives of this performance study are to:
- Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices.
- We will assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Inc.) and a similar device.
- assess user documentation comprehension
- obtain feedback on the Pivot Breath Sensor via rating scales.
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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California
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Redwood City、California、アメリカ、94063
- Carrot Inc.
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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:
- 18-80 years of age
- Owns and uses a smartphone
- Willing to sign the Informed Consent Form
- Resident of the United States
- Able to read and comprehend English
Exclusion Criteria:
- Prior experience with a study sponsored by Carrot Inc.
- Pregnancy
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：他の
- 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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他の：18-80 years of age
Single day study collecting 1 paired breath sample from each subject using two non-invasive breath sampling devices, as well as collecting participant responses to user documentation questions and rating scales.
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Collect breath sample from the Pivot Breath Sensor to measure the carbon monoxide in the participant's exhaled breath, along with recording responses to user documentation questions and rating scales.
Collect breath sample from a similar breath sensor to measure the carbon monoxide in the participant's exhaled breath.
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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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User Performance of Pivot Breath Sensor
時間枠：Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session.
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Assess user performance of the study device at a single visit. Participants will be observed if they can set up the Pivot Breath Sensor, and whether they can use the device. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors. "Successful" = the participant was able to complete the task independently, safely, effectively, and without difficulty. "Unsuccessful" = the participant was unable to complete the task independently, safely, effectively, and/or without difficulty. Includes instances where the participant required study moderator assistance. |
Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session.
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Compare Performance of Pivot Breath Sensor With a Similar Device.
時間枠：Each study session lasted up to 60 minutes per participant.
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Compare study device performance with a similar device at a single visit. Participants will then be asked to use a similar CO breath sensor device. The correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Sense) and the similar breath sensor will be assessed. |
Each study session lasted up to 60 minutes per participant.
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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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User Documentation Assessment With Observer Ratings
時間枠：Each study session lasted up to 60 minutes per participant. The user documentation assessment with observer ratings was done between approximately 10 and 35 minutes into the study session.
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Participant understanding of user documentation will be assessed at single visit through interpretation of three different CO test results: green, orange, and red. User documentation used for the interpretation of each result includes: packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'. "Successful" = the participant was able to complete the task independently, safely, effectively, and without difficulty. "Unsuccessful" = the participant was unable to complete the task independently, safely, effectively, and/or without difficulty. Includes instances where the participant required study moderator assistance. Participant will be asked to assess the user documentation throughout the study session and will take approximately 10 minutes. |
Each study session lasted up to 60 minutes per participant. The user documentation assessment with observer ratings was done between approximately 10 and 35 minutes into the study session.
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Participant Feedback Using Rating Scale
時間枠：Each study session lasted up to 60 minutes per participant. Use performance was assessed with rating scales at approximately 35 minutes into the study session.
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Participant will be asked to provide ratings on the following:
The participant will use the following rating scale: 5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult 1 - Very Difficult Not Applicable Participant will provide the ratings prior to the conclusion of the study session. Participant assessment with questionnaire rating scales will take approximately 1-2 minutes each. |
Each study session lasted up to 60 minutes per participant. Use performance was assessed with rating scales at approximately 35 minutes into the study session.
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協力者と研究者
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。
Pivot Breath Sensor Systemの臨床試験
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Institut de Myologie, FranceAparito Ltd.募集