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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03135678
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Hilbert Paradox NV

Brief Summary:

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.


Condition or disease
Healthy

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Study Type : Observational [Patient Registry]
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Observe Pilot, a Prospective Study to Verify the Feasibility of Collecting a Broad Variety of Individual Health Data
Actual Study Start Date : May 12, 2017
Actual Primary Completion Date : May 23, 2017
Actual Study Completion Date : May 23, 2017



Primary Outcome Measures :
  1. The number of subjects willing to join the study [ Time Frame: Through study completion, an average of 6 months ]
    The number of subjects invited compared to the number of patients willing to join

  2. The number of health data types that were measured [ Time Frame: Through study completion, an average of 6 months ]
    The number of health data types that were measured compared to the number of health data types anticipated



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The population is a healthy population.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135678


Locations
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Belgium
General Practice
Antwerp, Belgium, 2018
Sponsors and Collaborators
Hilbert Paradox NV
Investigators
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Principal Investigator: Stefan Verheye, MD, PhD Director at Hilbert Paradox

Additional Information:

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Responsible Party: Hilbert Paradox NV
ClinicalTrials.gov Identifier: NCT03135678    
Other Study ID Numbers: OBS_001
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No