Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-30 @ 5:52 AM
Study NCT ID:
NCT05370066
Status:
UNKNOWN
Last Update Posted:
2022-05-11
First Post:
2022-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose Measurement of Blood Pressure
Sponsor:
CardiacSense Ltd.
Organization:
Study Overview
Official Title:
Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose of Developing Continuous, Absolute, Non-Inflating Measurement of Blood Pressure
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BPW
Brief Summary:
This study is performed on hospitalized subjects in the Internal Medicine Division. The study is intended for data collection. The data will be obtained from commercially available blood pressure monitors and simultaneously from the CS6BP watch.
Detailed Description:
This is a prospective open-label study. Hospitalized subjects from Internal Medicine Division will be measured simultaneously with a commercially available blood pressure monitor and CS6BP watch. Subjects may be measured at the clinic or home up to one month following their discharge from the hospital.
Screening:
PI or delegated physician will confirm the eligibility of subjects. Eligible subjects will sign an informed consent form before any study procedure initiation.
Recording session during hospitalization:
Each subject will undergo up to 15 blood pressure measurement sessions during the hospitalization period. The subject will be connected to the CS6BP device and a cuff simultaneously during the session. There will be at least 30 minutes intervals between the end of the session to the beginning of the next session.
Recording session during follow-up:
The study team personnel may schedule up to 10 follow-up visits with the subject at the clinic or the subject's home for three months following discharge from the hospital. Up to 3 measurement sessions will be conducted during each follow-up visit, maintaining 30 minutes intervals between sessions.
In case of participant discomfort or mechanical hindrance from the watch, the medical staff will stop data collection. The subject can ask to remove the watch during data collection.
Screening:
PI or delegated physician will confirm the eligibility of subjects. Eligible subjects will sign an informed consent form before any study procedure initiation.
Recording session during hospitalization:
Each subject will undergo up to 15 blood pressure measurement sessions during the hospitalization period. The subject will be connected to the CS6BP device and a cuff simultaneously during the session. There will be at least 30 minutes intervals between the end of the session to the beginning of the next session.
Recording session during follow-up:
The study team personnel may schedule up to 10 follow-up visits with the subject at the clinic or the subject's home for three months following discharge from the hospital. Up to 3 measurement sessions will be conducted during each follow-up visit, maintaining 30 minutes intervals between sessions.
In case of participant discomfort or mechanical hindrance from the watch, the medical staff will stop data collection. The subject can ask to remove the watch during data collection.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CL00600 | REGISTRY | MOH | View |