Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05687578
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-03-30
First Post:
2023-01-03
Brief Title:
PUER Previously Unrecognized Emerging Risks Life Clinical Study
Sponsor:
Puer Research LLC
Organization:
Puer Research LLC
Study Overview
Official Title:
A Prospective Non-Randomized Multi-Center Observational Study to Establish a Physical Baseline Profile for Individual Study Subjects Using Various Modalities and Identify Deviations Via Longitudinal Monitoring That May Develop Over Time
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PUER
Brief Summary:
This is a minimal risk prospective non-randomized multi-center population based observational study to establish a physical baseline profile for individual study subjects using various modalities blood draws non-invasive imaging stool samples saliva samples and identify deviations through longitudinal monitoring that may develop over time and may be relevant to human health and healthy longevity
Detailed Description:
The two key elements of the PUER Research protocol include 1 molecular and laboratory profiling and 2 non-invasive imaging and wearables quantified self measurements All elements are optional Molecular assessments will be conducted using peripheral blood samples and potentially urine stool or saliva samples Non-invasive imaging assessment will consist of magnetic resonance imaging MRI and computerized tomography CT scans ultrasound and x-ray All imaging modalities are optional Other functional assessments including respiratory cardiac and other functions as well as self-quantifiable assessments via wearables may also be conducted and are optional
The study will result in longitudinal data collection to inform if any modalities employed here can inform of baseline deviations for individuals Researchers at study sites will not be blinded to the data being collected during this study
The study will result in longitudinal data collection to inform if any modalities employed here can inform of baseline deviations for individuals Researchers at study sites will not be blinded to the data being collected during this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None