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

NCT07775495

Not Yet RecruitingN/A

Sponsor: Ecotera Health LLC

Conditions: Healthy Adult Participants

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (51)

Birmingham, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
San Francisco, California, United States
Denver, Colorado, United States
Hartford, Connecticut, United States
Dover, Delaware, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Augusta, Maine, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Manchester, New Hampshire, United States
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