Observational Study of Decentralized Urine Optical Interaction Patterns Associated With Environmental Microplastic and Nanoplastic Exposure

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.

Eligibility Criteria