BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study
1 other identifier
observational
10
1 country
1
Brief Summary
The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2014
CompletedFirst Posted
Study publicly available on registry
May 8, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 26, 2014
June 1, 2014
Same day
May 6, 2014
June 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
adhesive performance/durability
The study will evaluate adhesive performance/durability by evaluating the Signal Quality of ECG data on the subjects (5 men and 5 women) in accordance with the requirements of FDA's ECG Electrode Guidance (section 5.A.3)1 and the ANSI/AAMI EC-12 Disposable ECG electrode technical standard (sections 4.4 and 5.4)2.
7 days
Secondary Outcomes (1)
human factors
7 days
Eligibility Criteria
cardiac patients followed at the study site's location
You may qualify if:
- cardiac patient volunteers (5 male and 5 female)
You may not qualify if:
- skin rash or infection over the sternum
- Sternal incision within 3 months from the date of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
EvergreenHealth
Enumclaw, Washington, 98022, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Gene Trobaugh, MD
EvergreenHealth
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2014
First Posted
May 8, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 26, 2014
Record last verified: 2014-06