Trial Outcomes & Findings for A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients (NCT NCT05853380)

Last Updated: 2025-11-03

Results Overview

The primary endpoint is a comparison to an FDA-cleared reference device to establish that PR measured with the IVC App is accurate.

Recruitment status

COMPLETED

Target enrollment

86 participants

Primary outcome timeframe

120 seconds

Results posted on

2025-11-03

The study recruited subjects from clinics, hospitals, and the general public. The study was conducted in the United States.

Participant milestones
Measure	Single Arm Open Label, Single Group Assignment
Overall Study STARTED	86
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	4

Withdrawal data not reported

ECG HR is reported for the 69 subjects with comparator data.

Baseline characteristics by cohort
Measure	Single Arm n=82 Participants Open Label, Single Group Assignment
Age, Continuous	48.7 Years n=82 Participants
Sex: Female, Male Female	42 Participants n=82 Participants
Sex: Female, Male Male	40 Participants n=82 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=82 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=82 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=82 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=82 Participants
Race (NIH/OMB) Asian	5 Participants n=82 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=82 Participants
Race (NIH/OMB) Black or African American	32 Participants n=82 Participants
Race (NIH/OMB) White	41 Participants n=82 Participants
Race (NIH/OMB) More than one race	1 Participants n=82 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=82 Participants
Region of Enrollment United States	82 participants n=82 Participants
IVC App Pulse Rate	69.0 Beats per Minute n=69 Participants • ECG HR is reported for the 69 subjects with comparator data.
IVC App Report Rate	69 Participants n=82 Participants • IVC App successfully reported the Pulse Rate for 69 of 82 subjects

Timeframe: 120 seconds

Population: Intent to Capture

The primary endpoint is a comparison to an FDA-cleared reference device to establish that PR measured with the IVC App is accurate.

Outcome measures
Measure	Single Arm n=82 Participants Open Label, Single Group Assignment
Pulse Rate Accuracy	67 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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