- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07223164
Validering af Masimos algoritme til detektion af uregelmæssig hjerterytme hos deltagere uden hjerte-kar-sygdom
This study is designed to validate the performance of Masimo Irregular Heartbeat Detection algorithm using Masimo SET® in detecting atrial fibrillation. The measurements will be compared to results obtained from Masimo Radius VSM®.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
Irvine, California, Forenede Stater, 92618
- Masimo Corporation
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
-
Subject is 18 to 80 years of age.
-
Comfortable to read and communicate in English.*
-
Subject passes the health assessment conducted by qualified study personnel, confirming they are in adequate health to participate in the required procedures
- This is to ensure the participant can provide informed consent and can comply with study procedures (as study material are currently available in English only).
Exclusion Criteria:
- Subject currently has a known cardiac disease condition.
- Subject is pregnant or breastfeeding.
- Subjects with a skin condition affecting the digits/chest, where the sensors are applied which would interfere with the path of lights (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown) or sensor adhesion.
- Skin condition which would preclude proper ECG placement.
- Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them.
- Subject is allergic to any supplies used in the study (e.g., ECG gel, adhesives).
- Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Specificity of Irregular Heartbeat Detection (using Masimo SET®)
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo SET® sensor. |
Pulse oximeter device |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Specificity Measures the % of True Negatives for Atrial Fibrillation Detection in Participants With Normal Sinus Rhythm.
Tidsramme: 1-2 hours
|
Specificity was calculated as the percentage of participants with normal sinus rhythm correctly identified by the Irregular Heartbeat Detection algorithm (using Masimo SET®) as not having atrial fibrillation (true negatives). Specificity = True Negatives ÷ (True Negatives + False Positives) × 100%. |
1-2 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CIP-1102
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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