trial testing Evaluation of the ECG signal in the nominal location and in three alternate positions in ECG Monitoring in 49 participants. Completed in 16 March 2025.
Timeline
1 January 2025
Primary endpoint 5 February 2025
16 March 2025
Quick facts
Lead sponsor
Seers Technology Co., Ltd.
Status
Completed
Study type
OBSERVATIONAL
Enrollment
49
Start date
1 January 2025
Primary completion
5 February 2025
Estimated completion
16 March 2025
Sites
1 location across United States
Drugs / interventions tested
Evaluation of the ECG signal in the nominal location and in three alternate positions
18 and older, any sex, with ECG Monitoring. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate PositionsPrimary· 2 minutes while the patient ambulates
Evaluation of the ECG signal at the nominal location and in up to three (3) additional alternate positions (AP) in each subject to determine if the signal is interpretable. The term "interpretable" is defined as follows: An independent cardiologist reader is able to identify the ECG rhythm in each location when compared to the ECG rhythm measured in the nominal position of the mobiCARE™ Cardiac Monitoring System described in the Instructions for Use. ECG rhythm data will be collected for up to two (2) minutes while the patient ambulates.
ECG rhythm data were collected in each location during
Group
Value
95% CI
Nominal Location
49
Alternate Position 1
49
Alternate Position 2
49
Alternate Position 3
49
Presence of Artifact GradedSecondary· 2 minutes
Presence of artifact graded as 1=none, 2=minor (cardiac rhythm is interpretable), or 3=major (cardiac rhythm is not interpretable by the independent cardiologist).
Group
Value
95% CI
Nominal Location
35
Alternate Position 1
21
Alternate Position 2
28
Alternate Position 3
31
Nominal Location
9
Alternate Position 1
14
Alternate Position 2
11
Alternate Position 3
11
Nominal Location
5
Alternate Position 1
14
Alternate Position 2
10
Alternate Position 3
7
Nominal Location
0
Alternate Position 1
0
Alternate Position 2
0
Alternate Position 3
0
Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate PositionsSecondary· 2 Minutes
The number of measurable positions for QRS amplitude and QRS duration at the nominal position and up to 3 alternate positions.
Group
Value
95% CI
Nominal Position
49
Alternate Position 1
49
Alternate Position 2
49
Alternate Position 3
49
Human Factors Evaluation MeasuresSecondary· 2 Minutes
Usability Performance Evaluation for Health Care Professionals and Subjects
How easy/difficult for the HCP to place device/electrodes in the Nominal Location using the IFU?
Group
Value
95% CI
Limited Human Factors Evaluation Measures
3.94
± 0.92
Could the HCP read the ECG signal on app to confirm Lead II/clear signal after the device placed?
Group
Value
95% CI
Limited Human Factors Evaluation Measures
4.43
± 0.74
How easy/difficult for subject to remove the device/electrodes from Alternate location 3?
Group
Value
95% CI
Limited Human Factors Evaluation Measures
4.1
± 1.01
How easy or difficult was it for the subject to remove the used electrodes from the mobiCARE™?
Group
Value
95% CI
Limited Human Factors Evaluation Measures
3.67
± 1.13
How easy/difficult for subject to replace electrodes with new electrodes on the mobiCARE™ device?
Group
Value
95% CI
Limited Human Factors Evaluation Measures
3.69
± 1.29
How easy or difficult was it for the subject to locate the markings for the nominal position?
Group
Value
95% CI
Limited Human Factors Evaluation Measures
3.49
± 1.23
How easy/difficult for subject to replace new mobiCARE™ device (electrodes) in the Nominal position
Group
Value
95% CI
Limited Human Factors Evaluation Measures
3.78
± 1.23
The Number of Measurable Positions for P-wavesSecondary· 2 minutes
Informational data collected to evaluate interpretability based on P-wave amplitude
Group
Value
95% CI
Nominal Position
48
Alternate Position 1
48
Alternate Position 2
48
Alternate Position 3
48
Sponsor's own description
Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT05895682 — A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunt
· NA
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Seers Technology Co., Ltd.
Last refreshed: 9 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06896734.