Avicena LVDP Validation Study in Healthy Volunteers

Completed

• Conditions: Healthy

• Registration Number: NCT05673174
• Lead Sponsor: Avicena LLC

Brief Summary

The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-16
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2022-11
• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Last Update Submitted: 2022-12-21
• Study First Posted: 2023-01-06
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

1. Adult subjects >21 years of age.
2. No known significant health problems.
3. Willing and able to participate in all study evaluations.
4. Ability to understand and sign informed consent.

Exclusion Criteria

1. Open skin lesions at the site of Vivio application / examination.
2. Inability to obtain brachial artery blood pressure.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To construct an algorithm from training data set to be used to estimate the ROC curve from the algorithm for a separate test data set.	3 months

Trial Locations

Locations (1)

Avicena; 🇺🇸 Pasadena, California, United States