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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEcotera Health LLC

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

15 Participants
are grouped into 1 trial group

Sponsors and collaborators