Recruiting

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

Sponsor:

Ecotera Health LLC

Code:

NCT07775495

Conditions

Healthy Adult Participants

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Healthy Adult Participants

Study ID

NCT07775495

Start date

Oct 21, 2026

Status verified date

Sep, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

EcoExposure Urine Observational Cohort

All 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 ]
Percentage of Completed Study Visits With All Required Study Data [ Time Frame: Throughout the study (Day 0 to Day 84) ]

Central Contacts and Locations

Central contacts

Cameron Y. Research Coordinator, M. Phil

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information