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Clinical Performance Evaluation of the Hativ P30

NCT06713226 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-02-18

No results posted yet for this study

Summary

Hativ P30 is intended to record, store, and transfer one-and two-channel ECG rhythms, and analyze them based on an artificial intelligence (AI) algorithm. In single channel mode, Hativ P30 can record lead-I. In two-channel mode, Hativ P30 can record lead-I and lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The ECG signal measured through the device's electrode is converted into a digital signal and transmitted via Bluetooth to an Android or iOS-based smart device with a mobile app installed. The ECG signal and analysis result can be checked through the screen of the smart device.

The aim of this clinical study is to assess the safety and efficacy of the Hativ P30 ECG recording device, as well as to gather data to support an FDA submission through the 510(k) process for the device's commercialization.

Conditions

Interventions

DEVICE

Hativ P30 and 12-lead ECG comparator device

The purpose of this study is to compare the clinical equivalence and diagnostic ability of the Hativ P30 against the 12-lead ECG comparator device. Electrocardiograms of all participants will be obtained using both the Hativ P30 and a 12-lead ECG comparator. That is, all participants will get the same intervention.

Sponsors & Collaborators

  • VUNO Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2025-07-23
Completion
2025-07-23
FDA Device
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06713226 on ClinicalTrials.gov