Study to Verify the Feasibility of Collecting a Broad Variety of Individual Health Data

Observe Pilot, a Prospective Study to Verify the Feasibility of Collecting a Broad Variety of Individual Health Data

The purpose of the OBSERVE PILOT is to verify the feasibility of collecting individual health data which is obtained through blood samples, continuous monitoring devices, medical imaging, a questionnaire, and a blood pressure monitor.

Feasibility of collecting individual health data within the OBSERVE PILOT is described as the ease of gathering a broad variety of data by assessing: (1) the willingness of the subjects to participate in the study, (2) the logistics corresponding with the variety, and (3) the regulatory aspects of gathering a broad variety of data.

Study Overview

• Status: Completed
• Conditions: Healthy

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2018
    • General Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population is a healthy population.

Description

Inclusion Criteria:

• The subject is able and willing to provide written informed consent prior to research specific data collection.
• The subject must be older than 18 years old.

Exclusion Criteria:

• The subject should not suffer from glaucoma.
• The subject should not be allergic to eye drops.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of subjects willing to join the study	The number of subjects invited compared to the number of patients willing to join	Through study completion, an average of 6 months
The number of health data types that were measured	The number of health data types that were measured compared to the number of health data types anticipated	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Hilbert Paradox NV
• Investigators: Principal Investigator: Stefan Verheye, MD, PhD, Director at Hilbert Paradox

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2017
• Primary Completion (Actual): May 23, 2017
• Study Completion (Actual): May 23, 2017

Study Registration Dates

• First Submitted: April 22, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 29, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: OBS_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No