Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-03-11 @ 8:59 AM
Study NCT ID:
NCT02634359
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-07-29
First Post:
2015-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of EarlySense for Monitoring Ovulation Cycles and Detection of Early Stages of Pregnancy in Home Environment
Sponsor:
EarlySense Ltd.
Organization:
Study Overview
Official Title:
Protocol for Evaluation of EarlySense - a Contact-less Heart and Respiration Device for Monitoring Ovulation Cycles and Detection of Early Stages of Pregnancy in Home Environment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2018-01
Last Known Status:
None
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:
None
Brief Summary:
The study objective is to collect data to assess the accuracy and reliability of Earlysense fertility cycle monitoring performance vs. acceptable known reference methods such as blood tests and intra-vaginal Ultrasound currently used as validated methods to detect ovulation and pregnancy. In addition the collected data will be used to further enhance and improve the existing algorithms.
Detailed Description:
The study objective is to assess the accuracy and reliability of Earlysense cycle monitoring to detect ovulation and implantation vs. acceptable known reference methods including blood tests and Ultrasound examination that are currently used as validated methods to detect ovulation and pregnancy. In addition the collected data will be used to further enhance and improve the existing algorithms that detect menses.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: