Observational Study of Decentralized Urine Optical Interaction Patterns Associated With Environmental Microplastic and Nanoplastic Exposure
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Ecotera Health LLC
- Study ID
- NCT07775495
- Status
- Not Yet Recruiting
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Conditions
- Healthy Adult Participants
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- First listed
- Aug 20, 2026
- Start date
- Aug 21, 2026
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2026
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 15 participants (estimated)
Arms
- Arm: EcoExposure Urine Observational CohortAll participants complete the same decentralized urine collection, preparation, and smartphone imaging workflow at scheduled timepoints over approximately 12 weeks. An optional technical reference (spike) sample may be offered; participants who choose this option add a small volume of a known-concentration reference solution to one prepared urine sample before imaging. This optional step is for internal assay and workflow evaluation only and does not create a separate analysis group or change the primary study procedures.
Primary Outcome Measure
Percentage of Scheduled Study Visits Completed by Participants [ Time Frame: From Day 0 to Day 84 ]
Central Contacts
- Cameron Y. Research Coordinator, M. Phil+15132787420
Locations (51)
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