HealthyNCT03135678
Study to Verify the Feasibility of Collecting a Broad Variety of Individual Health Data
An observational study of Healthy, run by Hilbert Paradox NV at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 12 May 2017to 23 May 2017
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population is a healthy population.
Who may be able to join
- 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.
Who cannot join
- The subject should not suffer from glaucoma.
- The subject should not be allergic to eye drops.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects willing to join the study
The number of subjects invited compared to the number of patients willing to join
Measured: 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
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start12 May 2017
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Hilbert Paradox NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Verheye, MD, PhD, Principal investigator, Director at Hilbert Paradox
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135678
- Sponsor's protocol ID
- OBS_001
- Status last verified
- May 2017
- First submitted
- 22 Apr 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observe Pilot, a Prospective Study to Verify the Feasibility of Collecting a Broad Variety of Individual Health Data
- ClinicalTrials.gov ID
- NCT03135678
- Acronym / sponsor ID
- OBS_001
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hilbert Paradox NVIndustry (pharma, biotech, devices)
- Study start
- 12 May 2017 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population is a healthy population.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- The subject should not suffer from glaucoma.
- The subject should not be allergic to eye drops.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Verheye, MD, PhD principal investigator
Director at Hilbert Paradox
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Hilbert Paradox NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects willing to join the study (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.