Healthy Adult Participants
Conditions
Keywords
environmental, environmental health, environmental exposure, microplastics, nanoplastics, urine, smartphone, feasibility, usability, at-home, decentratlized, observational, optical analysis
Brief summary
The goal of this observational study is to evaluate the feasibility and usability of at-home urine sample collection, preparation, and smartphone imaging using the EcoExposure™ platform in adults. The main questions it aims to answer are: Can participants successfully collect, prepare, and photograph urine samples at home and upload the images using a smartphone app? How consistent is image quality and participant adherence across repeated sampling over approximately 12 weeks? What is the short-term day-to-day variability in optical signals during an intensive daily sampling period? Participants will: Complete electronic consent and a brief intake questionnaire Collect and prepare urine samples at home at scheduled timepoints Capture guided smartphone photographs of the prepared samples Upload the images and provide brief feedback through the TrialKit app Optionally add a small reference solution (spike sample) to one sample for technical evaluation only The study is fully remote and lasts approximately 12 weeks. It is intended for product development and workflow validation purposes only and does not involve any diagnostic or clinical decision-making.
Detailed description
This is a decentralized, observational, product-development study evaluating the EcoExposure™ platform for at-home urine sample collection, preparation, and smartphone-based imaging. The study is non-clinical and is not intended to diagnose, treat, or provide health risk assessments. Approximately \[X\] adult participants will be enrolled for a duration of about 12 weeks. All activities are performed remotely using the participant's own smartphone and the TrialKit platform for electronic consent, guided workflows, image capture, and data submission. Participants will collect and prepare fresh urine samples at home according to provided instructions, capture guided photographs of the prepared samples, and upload the images along with brief feedback. Sampling occurs at the following timepoints: Day 0 (baseline), daily from Day 7 through Day 14 (intensive short-term variability assessment), and then at Days 21, 28, 42, 56, 70, and 84. An optional technical reference ("spike") sample may be offered. Participants who choose this option will add a small volume of a known-concentration reference solution to one of their prepared urine samples before imaging. This step is solely for internal assay and workflow evaluation and will not be used for any clinical interpretation. Primary focus areas include participant adherence and completion rates, image quality and usability, workflow feasibility in a fully remote setting, and qualitative assessment of optical signal consistency over time (including comparison of native versus optionally spiked samples for internal development purposes only). No diagnostic claims, clinical endpoints, or treatment recommendations are involved. Results will support product development, workflow optimization, and assay calibration.
Interventions
None listed
Sponsors
Ecotera Health LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18 years or older * Able to provide electronic informed consent * Willing and able to collect and prepare urine samples at home according to study instructions * Own a smartphone capable of running the TrialKit application and capturing photographs * Willing to complete the required study visits over approximately 12 weeks
Exclusion criteria
* Unable or unwilling to perform the study procedures (urine collection, sample preparation, smartphone imaging, and data upload) * Any condition or circumstance that, in the judgment of the investigator, would prevent the participant from successfully completing the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Scheduled Study Visits Completed by Participants | From Day 0 to Day 84 | Percentage of all scheduled study visits completed by each participant during the 84-day study, including the daily sampling period on Days 7-14. |
| Percentage of Completed Study Visits With All Required Study Data | Throughout the study (Day 0 to Day 84) | Percentage of completed study visits containing all required study data, including recording required urine sample information and uploading images to the secure study app. This measure will be used to assess the feasibility of the decentralized at-home study workflow. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria | Across all scheduled timepoints (Day 0 to Day 84) | Percentage of uploaded urine sample images that meet predefined image quality criteria for analysis using the EcoExposure™ image-analysis method. |
| Participant Rating of Ease of Using the At-Home Urine Collection and Imaging Workflow | Across all scheduled timepoints (Day 0 to Day 84) | Participants will rate the ease of using the at-home urine collection and imaging workflow on a 5-point rating scale from 1 to 5, with higher scores indicating greater ease of use. |
| Change in EcoExposure™ Microplastic and Nanoplastic Optical Measurements During Daily Urine Sampling | Day 7-14 | Urine samples will be measured using the EcoExposure™ optical assay and an image-analysis method that analyzes photographs of the samples. The study will compare how microplastic- and nanoplastic-related optical measurements change within the same participant during daily urine sampling (Days 7-14). |
Countries
United States
Contacts
CONTACTCameron Y. Research Coordinator, M. Phil
STUDY_DIRECTORMelinda B. Chu, M.D. M.B.A.
Ecotera Health LLC
Outcome results
None listed